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

Catalog Number 66801280

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  malfunction  

Event Description

It was reported that the patient stopped himself the console for about 3 hours because he was bothered by the alarm of the device.The patient continued the therapy with a bandage that has been done by a nurse meanwhile the backup was received.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been returned for evaluation.Without this evaluation it has not been possible to establish a relationship between the device and reported events.If the device is returned then this evaluation will be re-visited.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 for the reported events has been reviewed, revealing further instances which are being monitored to determine if additional actions are required.It is noted that the patient turned off the device due to the alarm noise.Please note, alarm thresholds are set after thorough testing and are always set to ensure the complete safety of the patient.It is possible in extreme cases that the alarm may trigger inadvertently.In this instance therapy will still be delivered.We have been unable to determine a root cause on this occasion.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 DEVICE & POWER SUP
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 9881053
• MDR Text Key: 185748379
• Report Number: 8043484-2020-00208
• 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
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1