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

Device Problem Pumping Problem (3016)

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

Event Date 03/05/2018

Event Type  malfunction  

Event Description

It was reported that during a therapy with a pico device, the pump stopped working during the night.When the problem was found the next morning, the dressing was not compressed.

Manufacturer Narrative

The device was not evaluated due to no samples were returned for investigation.Investigation summary: we have now completed our investigation into the reported complaint.As of today, no product return or further information for this complaint has become available preventing a more thorough investigation.If the product becomes available in the future, this case will be reopened.Each pump is functionally tested by the supplier before shipment to smith & nephew.Any pump which fails to meet the predetermined acceptance criteria is rejected.As this pump has been released for sale, it can be confirmed that the device has passed all functional testing.On this occasion we are unfortunately unable to reach a definitive root cause of the problem due to insufficient information available for the device in question, however smith and nephew are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: UNKNOWN PICO
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 7376529
• MDR Text Key: 103661771
• Report Number: 8043484-2018-00073
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1