MAUDE Adverse Event Report: BLOOD PRESSURE MACHINE; SYSTEM, MEASUREMENT, BLOOD PRESSURE, NONINVASIVE

Device Problems Material Discolored (1170); Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

Changed pharmacies - "different" color and "shape".Also blood pressure readings not taken correctly.

• Brand Name: BLOOD PRESSURE MACHINE
• Type of Device: SYSTEM, MEASUREMENT, BLOOD PRESSURE, NONINVASIVE
• MDR Report Key: 9134827
• MDR Text Key: 160715517
• Report Number: MW5090104
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): Y
• 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: 09/20/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 120