MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TOUCH NON CONNECT 4TH ED DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66802134

Device Problem Application Program Problem (2880)

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

Event Date 09/04/2019

Event Type  malfunction  

Event Description

It was reported that during treatment the device gave the error message 4006.There was a delay of more than two hours in the case.

Manufacturer Narrative

H10.H3, h6: we have now completed the investigation for this complaint.A review of the device history showed that this unit passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest the device did not meet product specifications nor did it allege any product deficiencies upon release into distribution.Complaint history for the reported failure has been reviewed and shown that in the previous four years there have been further instances.These instances are being monitored to determine if additional actions are required.The device, used in treatment, has been returned for evaluation.A visual inspection found no issues, the functional evaluation found that the device displayed a 4006-error message, establishing a relationship between the reported failure and the device.The coin cell was replaced and the device then passed a functional test performing within expected parameters.The root cause was determined to be battery failure.The 4006-error message is displayed when the battery had become fully depleted, the coin cell battery stores time, date and device event history.When this message is displayed then the device must be returned for service as outlined in the instruction for use.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

The device, used in treatment, has been returned and evaluated establishing a relationship between the event reported and the device.A visual inspection found no defects, the functional evaluation found that upon start up the device displayed the 4006-error message, this message is displayed when the coin cell battery that stores time and date functions has depleted.The coin cell battery only discharges when the main battery has also been allowed to discharge.The coin cell battery was replaced and a functional test found no further fault, the main battery was able to charge and hold charge.A review of the device history showed that this unit passed all acceptance criteria and was compliant upon release for distribution.There were no indications to suggest the device did not meet product specifications nor did it allege any product deficiencies.Complaint history has been reviewed and similar instances have been recorded, these instances are being monitored, with additional work being conducted to prevent re-occurrences of this type.This complaint has now been closed and recorded as device performed within expected parameters.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: RENASYS TOUCH NON CONNECT 4TH ED DEVICE
• 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: 9148049
• MDR Text Key: 161013433
• Report Number: 8043484-2019-00692
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1