MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS TCH CLASS 2 POWER SPLY; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801286

Device Problems Arcing (2583); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, during a npwt, sparks were generated from the cord of a renasys tch class 2 power sply when the ac adapter was connected.The procedure was completed, without delay, using a s+n back-up device.Patient was not harmed.

Manufacturer Narrative

H3, h6: the device was returned for evaluation.A visual inspection was performed, the strain relief was found to be damaged as described.A documentation review was performed.The image supplied clearly shows that the strain relief has been damaged.The manufacturing records and processes for the reported batch contain no contributory factors, records confirm that this batch was manufactured, meeting the required specifications.All inspection and testing requirement was met the prior to release.Historical review details previous cases of this nature, which are considered isolated in scope and there are no open nor closed escalation actions.Related to this event type.The risk management files adequately captures both of the reported concerns, with no updates required.The probable cause is deemed to be that excess stress has been applied against the strain relief, by a user.No manufacturing, packaging, labelling, design, concerns nor adverse trend have been observed, therefore no corrective actions are deemed necessary.

• Brand Name: RENASYS TCH CLASS 2 POWER SPLY
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15786517
• MDR Text Key: 303841652
• Report Number: 8043484-2022-00201
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 40565126630
• UDI-Public: 40565126630
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801286
• Device Lot Number: C1713A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1