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

Model Number 68-1132

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

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 back of the plugged in npwt device that was sitting on the patient¿s dresser got too hot to the touch for the nurse and warped and melted the plastic backing of device.No injury occurred.Mdr being filed for potential harm.

Manufacturer Narrative

Supplemental report is being filed following the submission of the initial mdr report that was submitted on 1/18/2021 due to the investigation findings are available.Device released from qa to stock on 12/04/2018.No service reports were available at the time of this review.Job router was reviewed without issue.Device passed all tests.The sample was not returned for investigation; therefore, an evaluation of the complaint device for deficiency of construction could not be performed and the root cause remains unknown.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 april 30, 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.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 DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 14201 nw 60th ave.; miami lakes FL
• MDR Report Key: 11197688
• MDR Text Key: 228833691
• Report Number: 1423537-2021-00588
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 10885380153181
• UDI-Public: 10885380153181
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/02/2021

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
• Device Operator: Health Professional
• Device Model Number: 68-1132
• Device Catalogue Number: 68-1132
• Device Lot Number: 17837
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 01/19/2021
• Supplement Dates Manufacturer Received: 12/24/2020
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other