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

Model Number 66801496

Device Problem No Pressure (2994)

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

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, renasys go device failed to control negative pressure.It was noisy and also vibrating.No patient harmed, and no injury reported because this was found during service and repair.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device intended for use in treatment was returned for evaluation and we have established a relationship between the device and the reported event.A visual inspection found no defects.The functional evaluation found that the device was noisy and vibrating, could not generate and control negative pressure and the root cause identified as a defective vacuum pump.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history found other related events.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 GO
• Type of Device: 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: 11015296
• MDR Text Key: 221714362
• Report Number: 8043484-2020-04246
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00040565126944
• UDI-Public: 00040565126944
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 66801496
• Device Catalogue Number: 66801496
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1