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

Catalog Number WD66021496

Device Problem Overheating of Device (1437)

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

Event Date 12/11/2019

Event Type  malfunction  

Event Description

It was reported that the pump malfunctioned with the initial delivery.The pump ran like it has a seal for a minute.Then it would start running again and get hot to the touch.There were no delays, no back up and no patient harm reported.

Event Description

Pump malfunctioned with the initial delivery.The pump ran like it has a seal for a minute.Then it will start running again and gets hot to the touch.Besides, in the investigation during the functional evaluation, it was found the device failed the pressure test, confirming that the device could not generate or control negative pressure.The patient was not injured in any way.

• 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
• MDR Report Key: 9616659
• MDR Text Key: 175886710
• Report Number: 8043484-2020-00053
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: C-0286746
• 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: 01/22/2021

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: No Information
• Device Catalogue Number: WD66021496
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/22/2020
• Supplement Dates Manufacturer Received: 01/22/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1