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

Device Problems Failure to Reset (1532); Device Inoperable (1663)

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

Event Date 07/03/2017

Event Type  malfunction  

Event Description

It was reported the pump stopped working.Problem solving attempted but the pump did not re-start.

Manufacturer Narrative

(b)(4).

• 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 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: markus poettker ; scachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 6753275
• MDR Text Key: 81482854
• Report Number: 8043484-2017-00191
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2017
• 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: Initial
• Patient Sequence Number: 1