Patient Safety Exam 2026 Questions and
Answers
Adverse Defice Effect - Correct answer-an adverse event related to the use of an
investigational medical device.
NOTE 1: This definition includes adverse events resulting from insufficient or
inadequate instructions for use, deployment, implantation, installation, or
operation, or any malfunction of the investigational medical device.
NOTE 2: This definition includes any event resulting from use error or from
intentional misuse of the investigational medical device
Adverse Event - Correct answer-is either a malfunction or a deterioration in the
characteristics or performance of a sold medical device [including accessory(s) and
labelling] or use error, which either has caused or could have caused or contributed
to death, or serious injury to health of patients or other persons.
CAPA - Correct answer-(Corrective and Preventative Action) action taken by the
manufacturer to correct an issue, and/or to prevent such an issue from recurring.
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, FDA's Center for Devices and Radiological Health (CDRH) - Correct answer-is
responsible for regulating firms who manufacture, repackage, relabel, and/or
import medical devices sold in the United States.
Design Error - Correct answer-is a mistake made during the design phase of the
production process. Specifications are not appropriate for the conditions or
environment in which the device is to be used.
Device Design - Correct answer-the combination of details or features of a medical
device.Another error concerned noninvasive blood pressure (BP) tubing that was
mistakenly connected to I.V. tubing. The patient, who was being monitored in
theED with a noninvasive automatic BP device, also had an I.V. catheter. The BP
cuff tubing was disconnected when the patient went to the bathroom, and it was
reconnected upon his return. The patient's wife found the patient "blue from the
neck up." Despite resuscitation efforts, he died. The BP cuff tubing had been
connected to the I.V. catheter and had delivered about 15 mL of air. An autopsy
confirmed a fatal air embolus.
Environmental Error - Correct answer-an error in calculations that are being a part
of observations due to environment. A safety issue was reported when newly
purchased ventilators were placed into service in a trauma ICU. Staff immediately
noted that the ventilators had an alarm that was not audible when the patient-room
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Answers
Adverse Defice Effect - Correct answer-an adverse event related to the use of an
investigational medical device.
NOTE 1: This definition includes adverse events resulting from insufficient or
inadequate instructions for use, deployment, implantation, installation, or
operation, or any malfunction of the investigational medical device.
NOTE 2: This definition includes any event resulting from use error or from
intentional misuse of the investigational medical device
Adverse Event - Correct answer-is either a malfunction or a deterioration in the
characteristics or performance of a sold medical device [including accessory(s) and
labelling] or use error, which either has caused or could have caused or contributed
to death, or serious injury to health of patients or other persons.
CAPA - Correct answer-(Corrective and Preventative Action) action taken by the
manufacturer to correct an issue, and/or to prevent such an issue from recurring.
©COPYRIGHT 2025, ALL RIGHTS RESERVED 1
, FDA's Center for Devices and Radiological Health (CDRH) - Correct answer-is
responsible for regulating firms who manufacture, repackage, relabel, and/or
import medical devices sold in the United States.
Design Error - Correct answer-is a mistake made during the design phase of the
production process. Specifications are not appropriate for the conditions or
environment in which the device is to be used.
Device Design - Correct answer-the combination of details or features of a medical
device.Another error concerned noninvasive blood pressure (BP) tubing that was
mistakenly connected to I.V. tubing. The patient, who was being monitored in
theED with a noninvasive automatic BP device, also had an I.V. catheter. The BP
cuff tubing was disconnected when the patient went to the bathroom, and it was
reconnected upon his return. The patient's wife found the patient "blue from the
neck up." Despite resuscitation efforts, he died. The BP cuff tubing had been
connected to the I.V. catheter and had delivered about 15 mL of air. An autopsy
confirmed a fatal air embolus.
Environmental Error - Correct answer-an error in calculations that are being a part
of observations due to environment. A safety issue was reported when newly
purchased ventilators were placed into service in a trauma ICU. Staff immediately
noted that the ventilators had an alarm that was not audible when the patient-room
©COPYRIGHT 2025, ALL RIGHTS RESERVED 2
