MAUDE Adverse Event Report: UNKNOWN FULL-ELECTRIC 9153638225; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Model Number UNKNOWN

Device Problems Fire (1245); Explosion (4006)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 10/04/2022

Event Type  Death  

Event Description

A letter was received from a technical services coordinator from fire cause analysis stating they are investigating a fire loss involving an invacare electrically powered bed.News reports indicated a fire occurred at an assisted living facility which resulted in the death of one resident and at least 5 residents transported to local hospitals.The news articles also indicated the fire was the result of oxygen cylinders that were present and was a human caused fire.

Manufacturer Narrative

This issue is being reported in an abundance of caution due to the involvement of an invacare bed.What limited information that is available was obtained from a letter received from a law firm sting only that an invacare bed was involved, and news reports which stated oxygen cylinders were involved and the cause was human activity.There was one death and numerous injuries associated with this event.Based on news reports its believed at least 5 of those injuries were transported to local hospitals.Attempts are currently ongoing to obtain further information regarding this incident.However, at this time limited information is available.Identifying information on the bed was unavailable and the only indication was that it was an invacare electrically powered bed.At this time the most likely underlying cause of this incident was the user smoking in the bed which resulted in oxygen cylinders that were present exploding.The identifying information on the oxygen cylinders hasn¿t been provided but has been requested.The manufacturing location of the bed is unknown therefore for filing purposes the manufacturing location will be selected as taylor street.If further information becomes available a follow-up medwatch will be filed.

• Brand Name: FULL-ELECTRIC 9153638225
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): UNKNOWN
• Manufacturer (Section G): UNKNOWN
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 15736423
• MDR Text Key: 303093553
• Report Number: 1525712-2022-00010
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization