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

Model Number 6701132

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Overheating of Device (1437)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation into this reported incident is on-going while we continue to gather further details related to the event.A follow-up report will be filed once the results have been completed.

Event Description

The distributor reported the pcb board and wires are burned and the device needs to be serviced.No other information was provided.

Manufacturer Narrative

Supplemental report being filed since sample device received for evaluation.Device released from qa to stock on (b)(6) 2019.No service reports were available at the time of this review.Job router was reviewed without issue.Device passed all tests.Complaint confirmed.Upon initial cosmetic defect inspection damage identified on the device case.When interior of device opened up for evaluation the pcb and wires were burned.Root cause is pump failure.Capa-ma029-01812 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.Ifu for sved device to be updated to include the warning for overheating and no direct contact of the device with patient.Update the service procedure to consider changing the motor is the motor has serviced more than 2000 hours.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.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.Cardinal health will continue to monitor the trend of this type of incident.

• 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
• MDR Report Key: 11720363
• MDR Text Key: 249443972
• Report Number: 1423537-2021-00624
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 22381
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other