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

Catalog Number 66801281

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

It was reported that the device's power cord melted.An electrician checked out the wall outlet and all was fine with the outlet so ce was called to check the unit out.It was possible to turn the unit on ¿on¿ battery power but could not plug into the outlet due to the missing part.No patient harm was reported but the cord was smoking according to the nurse.

Manufacturer Narrative

The device intended for use in treatment was returned for evaluation, establishing a relationship between the event reported.The functional evaluation found did not reveal any malfunction.The visual evaluation found scratched and cracked casing.It is not possible to determine the exact cause.However, factors that are known to contribute to this type of issue, included mishandling, drop damage, improper storage and the use of harsh abrasives and cleaning products.A review of manufacturing records for the reported lot/batch, found no non-conformances or anomalies during production.The device/product met all specifications upon release into distribution.Complaint history for the reported¿event has been reviewed, revealing further instances, however no further action is deemed necessary.Smith and nephew take all customer complaints and concerns seriously, we strive to have the best understanding of our patients needs and have built a strong culture of care, collaboration and courage to offer a service which we are proud of.

• Brand Name: RENASYS TOUCH DEVICE & POWER SUP
• 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: 9679395
• MDR Text Key: 178093797
• Report Number: 8043484-2020-00096
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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: Health Professional
• Device Catalogue Number: 66801281
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2020
• Initial Date FDA Received: 02/06/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1