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

Catalog Number 66801496

Device Problem Electrical Power Problem (2925)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2020

Event Type  malfunction  

Event Description

It was reported that during service evaluation the renasys go was found unable to operate on ac or battery power and could not recharge the battery due to a broken dc-inlet port.Additionally the pump had a motor leak.No patient involved.

Manufacturer Narrative

H10.H3, h6: the device, intended for use in treatment, was returned for evaluation.The visual inspection reported defects to the outer case.The functional evaluation confirmed the device could not be charged, establishing a relationship with the event reported.The root cause was identified as a broken main power inlet charging port.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported event has been reviewed, revealing further instances in the past three years.No further actions are deemed necessary at this stage.However, 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 GO
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU32B N; UK HU32BN
• MDR Report Key: 10305290
• MDR Text Key: 199822517
• Report Number: 8043484-2020-02140
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

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: 66801496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1