MAUDE Adverse Event Report: LINET LLC Protevo; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number 1VAKSB00000M0

Device Problem Break (1069)

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

Event Date 05/31/2017

Event Type  malfunction  

Event Description

Nurse attempted to turn on the air pump and the rocker switch broke.We have 11 of these pumps and this is the 3rd one that has broken.When the switch breaks off it leaves exposed contacts so there is a possible risk of shock.Manufacturer response for wound care air pump, protevo (per site reporter): they are aware that this is an issue and are looking in to it.

• Brand Name: Protevo
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): LINET LLC; 10420r harris oak blvd; charlotte NC 28269
• MDR Report Key: 6633122
• MDR Text Key: 77302249
• Report Number: 6633122
• Device Sequence Number: 0
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 1VAKSB00000M0
• Other Device ID Number: PROTEVO GTE+ MICROCLIMATE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1