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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH NPWT FACILITY NPWT SVED THERAPY DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

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CARDINAL HEALTH NPWT FACILITY NPWT SVED THERAPY DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Model Number 6701132
Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2021
Event Type  malfunction  
Manufacturer Narrative
The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.
 
Event Description
Customer reported the device was "smoking" and hot to the touch.Device disconnected from battery charger and removed from patient.Back of device shows signs of melting - likely where the battery is located.
 
Manufacturer Narrative
Supplemental report is being filed since investigation has been completed.Review of the device history record revealed the device was released to stock on 07/15/2020.The job router and the service records were reviewed without issues.Review of the serial number reported (15047) revealed the device passed all tests.The device was received for evaluation and tested for the issue reported "smoking, hot to the touch, and shows signs of melting.¿ temperature testing of the returned complaint pump and bench testing of aged pumps as part of the investigation revealed that the back panel temperature of a functional pump can reach between 40 and 50 degrees celsius while in operation.Temperatures measured during the testing remained within the acceptable limit of 60 degrees celsius.The device housings plastic is composed of fire-retardant material which has a 5va flammability rating at the wall thickness in the design and complies with the ul 94 standard.According to ul, 5va is the maximum flammability protection rating possible, and the key to this safety is if the device or plastic is self-extinguishing and is intended to mitigate the likelihood of a burn or fire and to reduce risk to a patient or care giver.As a result, the back panel provides significant protection against fire and the risk assessment conducted indicated that the probability of a hazardous situation leading to harm was low related to overheating.
 
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Brand Name
NPWT SVED THERAPY DEVICE
Type of Device
NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Manufacturer (Section D)
CARDINAL HEALTH NPWT FACILITY
8322 eagle palm drive
riverview FL
Manufacturer (Section G)
CARDINAL HEALTH NPWT FACILITY
8322 eagle palm drive
riverview FL
Manufacturer Contact
patricia tucker
3651 birchwood drive
waukegan, IL 60085
8478874151
MDR Report Key12957493
MDR Text Key283393098
Report Number1423537-2021-00696
Device Sequence Number1
Product Code OMP
UDI-Device Identifier10885380097454
UDI-Public10885380097454
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/08/2022
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? Yes
Device Model Number6701132
Device Catalogue Number6701132
Device Lot Number15047
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/11/2021
Initial Date FDA Received12/07/2021
Supplement Dates Manufacturer Received11/11/2021
Supplement Dates FDA Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2020
Is the Device Single Use? No
Type of Device Usage A
Patient Sequence Number1
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