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

Catalog Number 66800164

Device Problem Failure to Charge (1085)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Event Description

It was reported that during treatment the battery of the device refused to charge, even when plugged in.

Manufacturer Narrative

The reported device was received for evaluation at our testing facility.A visual inspection was performed on the exterior of product and no damage was observed.The reported complaint could not be confirmed but the device did arrive displaying an error message and the root cause was due to a defective pump motor.Following the complaint assessment, the device was sent to the service center to determine the full repair status/fate of the device.

Manufacturer Narrative

The associated complaint device was not returned for evaluation.(b)(4).

• Brand Name: RENASYS GO NPWT DEVICE
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: markus poettker ; scachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 7134232
• MDR Text Key: 95473404
• Report Number: 8043484-2017-00317
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 66800164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1