MAUDE Adverse Event Report: JOERNS HEALTHCARE RECOVER CARE, RECOVER AIR 3000; MATTRESS, AIR FLOATATION ALTERNATING PRESSURE

Model Number TD60-1

Device Problem Fire (1245)

Patient Problem Death (1802)

Event Date 02/21/2019

Event Type  Injury  

Event Description

Plug and cord caught fire at wall, code red called, fire extinguished.Last serviced 12/2018.Patient was in bed but had expired 30 minutes prior to fire.Family not at bedside.Nurse called code red and extinguished fire.Dates of use: (b)(6) 2015.Diagnosis of reason for use: to prevent pressure injury.

• Brand Name: RECOVER CARE, RECOVER AIR 3000
• Type of Device: MATTRESS, AIR FLOATATION ALTERNATING PRESSURE
• Manufacturer (Section D): JOERNS HEALTHCARE
• MDR Report Key: 8408450
• MDR Text Key: 138404248
• Report Number: MW5084794
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TD60-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR