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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
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 06/07/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
Customer reported that the device was not alarming for low pressure leak when there was a leak.Device was promptly discontinued and a replacement device was placed.Nurse further stated that there were no known injuries or adverse effects due to the reported concerns.No patient demographics were provided when requested.
 
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Brand Name
NPWT SVED THERAPY DEVICE
Common Device Name
NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Manufacturer (Section D)
CARDINAL HEALTH NPWT FACILITY
8322 eagle palm drive
riverview FL 33578
MDR Report Key12140914
Report Number1423537-2021-00648
Device Sequence Number3180691
Product Code OMP
UDI-Device Identifier10885380097454
UDI-Public10885380097454
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/09/2021
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
Operator of Device Health Professional
Device Model Number6701132
Device Catalogue Number6701132
Device Lot Number20300
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/11/2021
Initial Report FDA Received Date07/09/2021
Patient Sequence Number1
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