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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINET LLC PROTEVO; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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LINET LLC PROTEVO; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE Back to Search Results
Model Number 1VAKSB00000M0
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2017
Event Type  malfunction  
Event Description
Staff attempted to disconnect the cpr release and the hose connector breaks.This is the 3rd hose connector that has broken on one of these pumps.We only have 11 of these pumps and every bed requires one so when one goes down we have to remove a bed from service.Also we have only been using these beds and pumps for about 6 months so in 6 months almost 30% of our pumps have failed.Manufacturer response for wound care air pump, (b)(4) (per site reporter): they are aware that this is a problem and they are looking into it.
 
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Brand Name
PROTEVO
Type of Device
MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
Manufacturer (Section D)
LINET LLC
10420-r harris oaks blvd.
charlotte NC 28269
MDR Report Key6633131
MDR Text Key77303715
Report Number6633131
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Number1VAKSB00000M0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/31/2017
Device Age6 MO
Event Location Hospital
Date Report to Manufacturer05/31/2017
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/12/2017
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 Number1
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