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U.S. Department of Health and Human Services

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

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DRIVE MEDICAL / DRIVE DEVILBISS HEALTHCARE LIMITED DRIVE MEDICAL AUTOMATIC BLOOD PRESSURE MONITOR SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE Back to Search Results
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).
 
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Brand NameDRIVE MEDICAL AUTOMATIC BLOOD PRESSURE MONITOR
Type of DeviceSYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE
Manufacturer (Section D)
DRIVE MEDICAL / DRIVE DEVILBISS HEALTHCARE LIMITED
MDR Report Key9166159
MDR Text Key161691608
Report NumberMW5090244
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received10/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBP3600
Device Lot Number18051598BP3600
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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