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

Model Number 66800164

Device Problems Air Leak (1008); Device Alarm System (1012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2017

Event Type  malfunction  

Event Description

It was reported during npwt utilizing a renasys go pump, the pump didn't generate any alarm when the dressing was not being compressed due to an air leakage.

Manufacturer Narrative

(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 HU32B N; UK HU32BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 76. s meridan avenue; oklahoma city OK 73107
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6696400
• MDR Text Key: 79631728
• Report Number: 8043484-2017-00171
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 66800164
• Device Catalogue Number: 66800164
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2017
• 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: Unknown
• Patient Sequence Number: 1