MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE G-SERIES BED; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number G5510

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 10/04/2020

Event Type  malfunction  

Manufacturer Narrative

No injuries or property damage resulted from the event.The bed was not in use at the time of the incident.A photograph was provided of the bed¿s power supply showing where it had sustained thermal damage.At this time, the underlying cause is undetermined.The entire bed has been returned to invacare for evaluation.Once the findings are available, a supplemental record will be filed.

Event Description

The provider reported that a veteran's daughter noticed smoke and haze coming from the room where the g5510 bed was located.Upon inspection, the daughter stated she saw flames and smoke from the bed¿s power supply, which she immediately unplugged.

Event Description

The provider reported that a veteran's daughter noticed smoke and haze coming from the room where the g5510 bed was located.Upon inspection, the daughter stated she saw flames and smoke from the bed¿s power supply, which she immediately unplugged.

Manufacturer Narrative

The evaluation of the bed was completed.It was noted that there were scratches on the bed frame and slats, as well as the bed rails.Otherwise, the bed was intact.The pendant, along with its cable and connector, were also intact and undamaged.The top of the power supply housing showed no damage, nor was there any damage to the cables, connector, or plug.The damage was contained to the bottom of the power supply housing, which exhibited deformation by the serial number label.The power supply was opened, and it was observed that there was a failure on the top and bottom of the printed circuit board (pcb).This failure appeared to be the cause of the deformation to the power supply housing, and it most likely caused the smoke that was observed by the complainant.Because the bed's power supply was damaged, functional testing of the bed was conducted using an exemplar power supply.All functions were observed to operate properly, and there was no evidence of smoke or flames.The bed's power supply is being returned to the supplier for a more detailed evaluation to determine the cause of the pcb failure.Note: invacare received notification from the fda that the va also submitted a medwatch for this event.Reference mw5097256.

• Brand Name: INVACARE G-SERIES BED
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• MDR Report Key: 10754391
• MDR Text Key: 213627151
• Report Number: 1031452-2020-00040
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

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: No Information
• Device Model Number: G5510
• Device Catalogue Number: G5510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/29/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1