MAUDE Adverse Event Report: CVS PHARMACY INC. CVS BRAND MANUAL BLOOD PRESSURE CUFF; SYSTEM MEASUREMENT BLOOD PRESSURE - NONINVASIVE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/08/2018

Event Type  No Answer Provided  

Event Description

I purchased a manual blood pressure cuff from (b)(6) in (b)(6).I took the bp of a friend, whose typical blood pressure is 130/75, and my own, which is typically 110/60.The pressure gauge read 140/100 for both readings.I am a nurse, in practice for over 25 years, and very familiar with manual blood pressure practice.I returned the product to (b)(6) the next day and reported the problem to them and suggested that they have their (b)(6) nurse practitioners trial this product.Document number: (b)(4).Report number: (b)(4).

• Brand Name: CVS BRAND MANUAL BLOOD PRESSURE CUFF
• Type of Device: SYSTEM MEASUREMENT BLOOD PRESSURE - NONINVASIVE
• Manufacturer (Section D): CVS PHARMACY INC.
• MDR Report Key: 7925922
• MDR Text Key: 122629981
• Report Number: MW5080246
• Device Sequence Number: 1
• Product Code: DXN
• 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: 09/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1