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	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2020
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
Device got hot enough to cause some melting on the device.No additional information or patient demographics were provided upon request.Cardinal health is filing a report for potential risk.
Additional Manufacturer Narrative
During investigation the device history record (dhr) was reviewed and no issues were discovered- device passed all tests.The device was manufactured on 5/29/2013.Our investigation was limited to only the dhr review since the device was not returned for evaluation.Several attempts to obtain the device were made.
Additional Manufacturer Narrative
Supplemental report being filed to include corrective actions identified during the investigation and capa process.Capa has been opened and an investigation into the overheating complaints was conducted.The following corrective actions were identified to address the root causes identified during the investigation: instructions for use ( 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 as 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.These corrective actions are planned to be completed by april 30, 2021.

• 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: 10243078
• Report Number: 1423537-2020-00479
• Device Sequence Number: 3066241
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2021

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: No Information
• Device Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 13328
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/12/2020; 06/12/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 10/02/2020; 02/15/2021
• Patient Sequence Number: 1