MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH DEVICE&POWER SPLY; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	66801280
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during npwt, the renasys tch device&power sply displayed a "collector full" alarm.When checked, the collector was completely empty, there was no problem with the tubing and the dressing was well sealed.The device was stopped and when restarting, a message appeared asking for "manufacturer maintenance".The device went back to therapy mode without any difficulty and did not alarm again, thus allowing the treatment to continue without changing the machine.The patient was not harmed.
Additional Manufacturer Narrative
H3, h6: the device, intended to be used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable causes may include maintenance procedure or component failure.The ifu offers further guidance.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: RENASYS TCH DEVICE&POWER SPLY
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11918466
• Report Number: 8043484-2021-01322
• Device Sequence Number: 3179635
• Product Code: OMP
• UDI-Device Identifier: 00040565126586
• UDI-Public: 00040565126586
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 66801280
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1