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

Catalog Number 66021496

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 04/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device intended for used in treatment was returned for evaluation establishing a relationship between the reported event and the device.A visual evaluation found that the casing was cracked, a functional evaluation found that device displayed the error message of ¿device failed and please return¿, therefore the root cause being an internal software failure.A review of manufacturing records for the reported lot number found no non-conformances or anomalies during production.The device met all specifications upon release into distribution.Instances for reported events are being monitored to determine if additional corrective actions are required.A complaint history for the reported event has been reviewed revealing further instances, however no further action is deemed necessary.This investigation is now complete with no further action deemed necessary at this time and we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.By acknowledging and investigating your complaint this collaboration enables us to drive our passion to continuously review, improve and steer our shared purpose of providing the best possible outcome for customer and patients.Smith and nephew take all customer complaints and concerns seriously, we strive to have the best understanding of our patients needs and have built a strong culture of care, collaboration and courage to offer a service which we are proud of.

Event Description

It was reported that canister was full.No patient involved, back up available.The investigation approved on (b)(6) 2020 confirmed that the device displayed the error message device failed please return.No patient involved.

• 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 ; UK
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 10731552
• MDR Text Key: 212959743
• Report Number: 8043484-2020-03281
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K152163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/23/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/05/2019
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1