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

Model Number 66801280

Device Problems Protective Measures Problem (3015); Suction Failure (4039)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  malfunction  

Event Description

It was reported that during service evaluation the renasys touch device was unable to start-up correctly and displayed error 4006 due to a defective coin cell.Additionally, the device was found unable to generate and control negative pressure due to a defective motor.No patient involved.

Manufacturer Narrative

H3, h6: the device, intended for use in treatment, has been returned and evaluated.Visual inspection reported no issues.The functional evaluation confirmed the device was unable to generate or control negative pressure, establishing a relationship between the device and the event reported.The root cause was determined as a failed vacuum motor.Additionally, the device displayed the 4006-error code on start up due to a depleted battery.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release.The complaint history review found further instances of the reported event in the past years.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TCH DEVICE&POWER SPLY
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10858267
• MDR Text Key: 216824179
• Report Number: 8043484-2020-03911
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00040565126586
• UDI-Public: 00040565126586
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66801280
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1