MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKN PICO 7; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number UNKN05004902

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Noise, Audible (3273); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 11/06/2021

Event Type  Injury  

Event Description

It was reported that, during wound therapy, while using an unknown pico 7 device, the patient experienced electrical shocks.In addition, the device was making abnormal sounds, different from the usual buzzing, and an "electrical burn" smell was perceived.The device was not used in a hyperbaric chamber, mri, nor does the patient have any medical devices that would cause interference.No further information is available.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

It was reported that whilst using an unknown pico 7 the patient experienced electrical shocks in addition the device was making abnormal sounds and an electrical burn smell was perceived.The pump had not been used in a hyperbaric chamber or mri.The device was used for treatment and was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.A complaint history review on the product family did not reveal any similar instances in the last three years.As no lot number or product code was provided it was not possible to carry out a device history review.A risk management review determined that although the failure modes are not directly linked to specific failure modes within the risk files there are several failure modes which can result in the reported failure modes and so the risk files mitigate the reported issues with no updates required.A clinical assessment determined that without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The most probable root cause for all of the reported failure modes within the event is that the device has been damaged at some point which has caused internal damage to the pump.This damage may then cause all of the described issues, especially if water had become present inside the device also.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device.It warns against water or moisture entering the device in section 9.1 and 6.15.This investigation is now complete, with no corrective actions 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.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• Brand Name: UNKN PICO 7
• 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: 12870272
• MDR Text Key: 281215601
• Report Number: 8043484-2021-01976
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKN05004902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1