MAUDE Adverse Event Report: DRIVE MEDICAL / DRIVE DEVILBISS HEALTHCARE LIMITED DRIVE MEDICAL AUTOMATIC BLOOD PRESSURE MONITOR; SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE

Model Number BP3600

Device Problem Break (1069)

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

Event Date 10/03/2019

Event Type  malfunction  

Event Description

I am not sure if this is the right contact but i have a problem and the company is not doing anything about it.I have a blood pressure monitor.The arm cuff has the hook and loop (velcro) fastening on it like every other that i have seen.On this one the little plastic hooks are breaking off when you separate the two parts.I just received the third arm cuff and separated the two parts over a clean sheet of paper.Three of the hooks broke off.I fastened it and separated it again and two more hooks broke off.As i was typing this email, i noticed another hook that was off the sheet of paper, and i just found another for a total of seven.I asked the company service rep if he has had that problem with anyone else before.He said that he had never heard of that problem.I looked at my previous contact with the company and found that it was the same csr that i dealt with before.He did have that problem before with me.Now little plastic hooks are not that much of a problem except that i found one on the kitchen counter.I never used the bp monitor in the kitchen.I am guessing that the hooks are designed to latch onto things and might have stuck onto a shirt and fallen off later in the kitchen.This is a problem when those hooks may be getting into food and other places.I did see if i could find anything at all about the hooks falling or breaking off.I could not find anything about that happening.I now have three cuffs for the blood pressure monitor and they all have the same problem.It is just the problem with the cuffs.I can't find any sort of model number or lot number on the cuffs.The picture included is the hooks that have broken off in just one week.Fda safety report id# (b)(4).

• Brand Name: DRIVE MEDICAL AUTOMATIC BLOOD PRESSURE MONITOR
• Type of Device: SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE
• Manufacturer (Section D): DRIVE MEDICAL / DRIVE DEVILBISS HEALTHCARE LIMITED
• MDR Report Key: 9166159
• MDR Text Key: 161691608
• Report Number: MW5090244
• 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: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BP3600
• Device Lot Number: 18051598BP3600
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1