MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. RENASYS GO V2; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801244

Device Problems Defective Alarm (1014); Break (1069); Suction Failure (4039)

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

Event Date 10/11/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).Initial reporter postal code: (b)(6).The device, intended for use in treatment, was returned for evaluation.A visual inspection reported the housing is damaged.Door flap is broken.The pump is contaminated.The functional evaluation reported the vacuum motor is defective and the low vacuum alarm did not display establishing a relationship between the device and the reported event.The root cause was identified as a defective vacuum motor and contact with another source.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Event Description

It was reported that, a renasys go v2 had the vacuum motor defective presenting suction failures, also did not show the low vacuum alarm indication and case was broken.As this was noticed upon service and repair activities, there was not patient involvement.

Manufacturer Narrative

Reassessment of this incident found it not to fulfill reporting criteria.The lack of an alarm or a ¿defective alarm¿ will not directly or indirectly cause or contribute to serious injury or death, even in a clinical setting.Additional conditions must also exist (e.G.Surgical / treatment conditions; patient factors; the unavailability of back-up or alternate therapies, loss of wound management / monitoring (conservatively defined as greater than 24 hours) before an injury could possibly occur, and even under those conditions, the risk of patient harm is low.This incident is considered not reportable pursuant to 21 cfr part 803.

• Brand Name: RENASYS GO V2
• 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: 12733109
• MDR Text Key: 279565105
• Report Number: 8043484-2021-01920
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 40565126418
• UDI-Public: 40565126418
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66801244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2021
• 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