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 Defective Device (2588); Application Program Problem (2880)

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

Event Date 04/23/2020

Event Type  malfunction  

Event Description

It was reported that the renasys touch pump displayed the message "contact your provider 4006" and it was not running as usual.It is unknown which procedure was being performed, when the event happened, if there was patient involvement, if there was a delay in the case and if a backup device was available.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information received by the manufacturer has identified that this event should be re-evaluated for mdr reporting, therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• 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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10077070
• MDR Text Key: 191664173
• Report Number: 8043484-2020-00494
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K181204
• 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: 09/24/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 09/24/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1