MAUDE Adverse Event Report: RECOVERCARE RECOVERAIRE; LOW AIR LOSS SPECIALTY MATTRESS

Model Number VCEOTE (3000 ELITE)

Device Problems Material Frayed (1262); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

While providing care to the patient, it was noticed that the bed tubing had become pulled tight in the side rail causing the wires to fray leading to sparks coming from the lower end of the bed.Fire alarm pull station was pulled.9-1-1 was called and the fire department arrived.No injury to patient.

• Brand Name: RECOVERAIRE
• Type of Device: LOW AIR LOSS SPECIALTY MATTRESS
• Manufacturer (Section D): RECOVERCARE; louisville KY 40223
• MDR Report Key: 3811805
• MDR Text Key: 4528470
• Report Number: MW5036076
• Device Sequence Number: 1
• Product Code: IOQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/08/2014

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: VCEOTE (3000 ELITE)
• Device Catalogue Number: 501215
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 65