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

Model Number WD000000000066800951

Device Problems Overheating of Device (1437); Device Inoperable (1663)

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

Event Date 06/14/2013

Event Type  malfunction  

Event Description

It was reported the pump had been in use less than 12 hours when it got very hot and died and when the patient took the pump into paula it was still hot and would not work.

Manufacturer Narrative

(b)(4).

• Brand Name: NPWT PICO STERILE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull; HU3 2 NB; UK HU3 2NB
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull; HU3 2 NB; UK HU3 2NB
• Manufacturer Contact: claudia odory ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 4887824
• MDR Text Key: 18036059
• Report Number: 8043484-2015-00139
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2013

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: Other
• Device Model Number: WD000000000066800951
• Device Catalogue Number: WD000000000066800951
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/14/2013
• Initial Date FDA Received: 07/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention