MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH C2 POWER SUPPLY; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801286

Device Problem Electrical Shorting (2926)

Patient Problem Electric Shock (2554)

Event Date 09/20/2018

Event Type  malfunction  

Event Description

It was reported that a transformer block has the wires exposed and a patient received an electrical shock.A medical intervention was not required.

Manufacturer Narrative

As of today, no sample or additional information requested for this complaint has become available.Without further information we cannot progress our investigation or confirm the details supplied in this complaint.In the absence of additional information, our investigation remains inconclusive.At this time an exact root cause cannot be determined.If additional information becomes available in the future, this case will be reopened.

Manufacturer Narrative

Our investigation into the complaint has now concluded.The device was sent to our technical centre so a thorough technical analysis could be carried out to help to identify if there were any problems and/or what could have caused the reason for the complaint.A visual inspection of the device found that the cable strain reliefs were damaged, however the reported malfunction was not observed during a functional evaluation as although internal wires were exposed the insulation on these was fully intact hence it is not possible for the patient to receive an electric shock from the device.Following the complaint device evaluation it was recommended that due to the exposed insulation in the power cord the device should be scrapped.Smith and nephew are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TOUCH C2 POWER SUPPLY
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull, HU3 2 8N; UK HU3 28N
• MDR Report Key: 7980923
• MDR Text Key: 124350604
• Report Number: 8043484-2018-00333
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 66801286
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1