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

Model Number	66021496
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, a renasys go was not beeping or displaying warnings.Patient had surgery to big toe on (b)(6) 2021, reported it was "non-healing" per his doctor requiring renasys go device on (b)(6) 2021.On (b)(6) 2021 he thought there was an "obvious leak" in his dressing and it was replaced that day: his doctor said he received therapy, because he hadn't heard any beeping then until now he didn't think he'd received therapy for 4 days.Frustrated he was calling about it failing to alert him of the leak monday and was worried it wasn't working properly asked current status of device and answered since (b)(6) 2021 a green light and continuous 120mmhg.Stated to patient that it was working as expected and he'd received therapy.Patient still questioning that the he had a leak on monday and it never beeped.Walked patient through resetting the device.Stated would trouble shoot and have a warning display and beep so it could be confirmed by patient and he was agreeable.Restarted device, after having him unplug it from charging, and it returned to continuous suction with green light.Uncapped quick click connector and continuous 120 mmhg displayed.Explained delivering therapy and to uncap connector to device.Beeped and displayed low vacuum.Patient felt tubing and said he could feel suction.Plugged connectors back up, resumed with compressed dressing to dressing site.Patient replicated trouble shooting and stated he didn't mention the beeping early with the warning display but it had.Patient then reflected on his dressing and stated underneath the "overall adhesive" it looked like there was a leak because of positioning on his toe.He thinks the adhesive was intact and was why he didn't hear or see anything after all.He then vocalized it had been dropped twice (b)(6) 2021 by the person placing it and replaced once, leaving a hair line crack.Treatment was performed with the same device.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.Probable cause may include kinks, leaks and blockages as detailed in the ifu, or a component failure.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications 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.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.The lack of an alarm/ alert or a defective alarm/ alert would not be likely to cause or contribute to death or serious injury, 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 or the loss of wound management/ monitoring for greater than 24 hours) before an injury could occur, and even under those conditions, the risk of patient harm is low.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.Device is intended to display an alarm/ alert if it detects an issue and may discontinue applying therapy until issue is resolved.Loss of negative pressure wound therapy benefits would not be likely to cause or contribute to death or serious injury.Event may cause minor or temporary injury (e.G., delayed wound healing, maceration, etc.) requiring no or minor medical intervention.Event may require use of a backup device to continue therapy.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.Device charging problem would not be likely to cause or contribute to death or serious injury, 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 for greater than 24 hours) before an injury could occur, and even under those conditions, the risk of patient harm is low.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.

• Brand Name: RENASYS GO
• Common Device Name: 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: 12389079
• Report Number: 8043484-2021-01702
• Device Sequence Number: 14346794
• Product Code: OMP
• UDI-Device Identifier: 05000223491000
• UDI-Public: 05000223491000
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K152163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: 66021496
• Device Catalogue Number: 66021496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/12/2021
• Supplement Date Received by Manufacturer: 10/05/2021; 10/05/2021
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 10/06/2021; 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown