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

Model Number	6701132
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
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
The customer reported the sved npwt device got so hot that it melted while plugged into the wall and the customer believes the device was on a resident, however they cannot confirm.No further information was provided upon request.
Additional Manufacturer Narrative
Supplemental report is being filed following the submission of the initial mdr report submitted on 3/2/2021 due to the investigation findings are available.Device released from qa to stock on (b)(6) 2017.Device was serviced on (b)(6) 2019, (b)(6) 2020.Job router was reviewed without issue.Device passed all tests.Complaint overheat of device confirmed.Investigation found a loose screw inside the pump.The loose screw may have caused the pump to seize and overheat.The overheated pump melted battery wires, buttons, tubing and back panel of the enclosure.The pump malfunction prevented the performance of investigation tests.Suggest replacing pump, battery, on/off buttons, tubing and back panel of enclosure.Root cause is pump failure.Capa (b)(4) was opened and an investigation into the overheating complaints was conducted.The following corrective actions were identified to address the root causes identified in the capa.These corrective actions are planned to be completed by (b)(6) 2021.1.Ifu for sved device to be updated to include the warning for overheating and no direct contact of the device with patient.2.Update the service procedure to consider changing the motor is the motor has serviced more than 2000 hours.3.Implement the service timer recording in the service procedure and forms to determine when to change the motor once the serviceable life has been exhausted.4.Install relay cut off mechanism at appropriate threshold temperature that will cut off the current to the motor in cases when motor may draw excessive current leading to overheating effect.

• Brand Name: NPWT SVED THERAPY DEVICE
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 14201 nw 60th ave.; miami lakes FL 33014
• MDR Report Key: 11408050
• Report Number: 1423537-2021-00607
• Device Sequence Number: 4189187
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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 Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 14911
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other