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

Catalog Number 66800164

Device Problem Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 11/09/2017

Event Type  malfunction  

Event Description

It was reported that the device shuts down repeatedly every minute which renders the exudates sustained in the dressings.

Manufacturer Narrative

After further review, it was determined that this report was filed in error.Please disregard.If further information is obtained that changes this determination, the investigation will be re-opened.

• 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: 7034839
• MDR Text Key: 92643497
• Report Number: 8043484-2017-00285
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 66800164
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2017
• 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