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

Catalog Number 66021496

Device Problems Suction Problem (2170); Defective Device (2588)

Patient Problem Tissue Damage (2104)

Event Date 01/22/2020

Event Type  Injury  

Event Description

It was reported that the patient has had the pump since (b)(6) 2019, over this time they have had leak and blockage alarms which could be solved quickly changing the canister or dressing.During the last 2 months, the patient feels like the pump is not making enough suction and the drainage is less than before.When the nurse went to change the dressing, she found out that the wound was starting to get macerated and the dressing was saturated.As the patient was no satisfied with the pump, they called rotech to ask for a new one.No patient harm was reported.

• 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: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 0447940038
• MDR Report Key: 9678695
• MDR Text Key: 178105464
• Report Number: 8043484-2020-00090
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 66021496
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other