MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO SINGLE USE NPWT 15 X 20CM; POWERED SUCTION PUMP

Model Number 66800955

Device Problem Device Inoperable (1663)

Patient Problem Pressure Sores (2326)

Event Date 08/28/2015

Event Type  malfunction  

Event Description

It was reported that the patient used pico for 3 days when the machine died.There was no alarm triggered.It has caused 2 days delay and allevyn dressing was used during these 2 days.Patient has contractures of both legs, resulting in pressure sores in some areas as a result.

• Brand Name: PICO SINGLE USE NPWT 15 X 20CM
• Type of Device: POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 3 BN; UK HU3 3BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; st petersburg, FL 33716
• MDR Report Key: 5161068
• MDR Text Key: 28979210
• Report Number: 8043484-2015-00284
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K111170
• 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: 08/31/2015

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: Lay User/Patient
• Device Model Number: 66800955
• Device Catalogue Number: 66800955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/07/2015
• Initial Date FDA Received: 10/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 58