MAUDE Adverse Event Report: ELECTRONIC BLOOD PRESSURE DEVICE; ALARM, BLOOD-PRESSURE

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Defective Device (2588); Protective Measures Problem (3015)

Patient Problem Unspecified Infection (1930)

Event Date 11/24/2021

Event Type  Injury  

Event Description

Patient called to report device issues with 3 different devices used at the facility where he is a resident.Patient stated that the thermometer, glucometer, and blood pressure measuring device used at the facility give inaccurate readings, error messages, and feels the devices need to be checked.Patient stated he does not feel the devices at the facility are up to code and are defective.Patient stated he's had an ongoing groin infection.

• Brand Name: ELECTRONIC BLOOD PRESSURE DEVICE
• Type of Device: ALARM, BLOOD-PRESSURE
• MDR Report Key: 12878255
• MDR Text Key: 281344722
• Report Number: MW5105606
• Device Sequence Number: 3
• Product Code: PZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/24/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male