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

Catalog Number 66801496

Device Problems Failure to Power Up (1476); Battery Problem (2885); Suction Failure (4039)

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

Event Date 07/22/2020

Event Type  malfunction  

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 that the outer casing was broken and the membrane on the user interface was damaged.The functional evaluation found that the device failed to charge; could not operate on ac or battery power, could not generate and control negative pressure and the root cause identified as a defective battery.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 at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

Event Description

It was reported that the device was found to be unable to start up correctly and the battery cannot keep the charge.No patient harmed and no injury reported because this was found during service and repair.After investigation it was noticed that the device could not generate and control negative pressure.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 11627977
• MDR Text Key: 244203517
• Report Number: 8043484-2021-00784
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 04582111155054
• UDI-Public: 4582111155054
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 66801496
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1