FDA Adverse Event
Death
Summary report: N
DRIVE ULTRALT.PLUSSEMI.ELEC.
MDR report key: 24781778
·
Received April 3, 2026
Report
- Report Number
- 2438477-2026-00016
- Event Type
- Death
- Date Received
- April 3, 2026
- Date of Event
- December 27, 2025
- Report Date
- May 12, 2026
- Manufacturer
- SHENYANG HENYI ENTERPRISE CO., LTD
- Product Code
- FNL
- UDI-DI
- 00822383111094
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
THE SEMI-ELECTRIC BED WAS INSPECTED BY SEVERAL EXPERTS REPRESENTING SEVERAL PARTIES. THE EVALUATION CONFIRMED THAT THE SEMI-ELECTRIC BED WAS NOT THE CAUSE OF THE FIRE IN THE REPORTED EVENT.
Description of Event or Problem · 0
DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED BY ATTORNEY LETTER OF THE PRESENCE AND POTENTIAL INVOLVEMENT OF A SEMI-ELECTRIC BED IN A FIRE, AND THE END USER WAS INJURED AND SUBSEQUENTLY DIED AS THE RESULT OF A FIRE. DRIVE DEVILBISS HEALTHCARE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO INSPECT THE PRODUCT THROUGH THE ATTORNEY. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21614 | DRIVE ULTRALT.PLUSSEMI.ELEC. | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | SHENYANG HENYI ENTERPRISE CO., LTD | 15030 | 00822383111094 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |