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

Catalog Number 66801280

Device Problem Excessive Heating (4030)

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

Event Date 07/02/2019

Event Type  malfunction  

Event Description

It was reported that the console was used yesterday on a patient.This morning, the nurse noticed that the device was warm.No injury or harm reported but without the battery, the patient could not move.It is unknown if there was a delay.

Manufacturer Narrative

H3, h6: the investigation for the reported complaint has now been completed.The device, intended for use in treatment, has been returned and evaluated.A visual inspection found no defects.A relationship between the reported failure and the device has been established.The functional evaluation found that the vacuum pump was defective, this was replaced and a further test was passed with the device performing within expected parameters.The report that the unit the unit felt warm to the touch would likely be due to the failed vacuum pump overworking.A result of this is the inbuilt safety feature, noted in the instruction for use.When the device reaches a set temperature the unit is prevented from further charging, this prevents damage to the battery and the device.This is the most likely reason why the unit was not able to charge and work on battery power.The root cause was determined to be a mechanical component failure.Manufacturing records reviewed found no non-conformances or anomalies during production and the device met all specifications upon release into distribution.Complaint history for both failures reported have been reviewed and similar instances have been found in the previous four years, further investigations are being conducted to determine if additional actions are required.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 TCH DEVICE&POWER SPLY
• 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: 8810439
• MDR Text Key: 151713846
• Report Number: 8043484-2019-00501
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K153210
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 03/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1