FDA Adverse Event
Death
Summary report: N
BEKA HOSPITEC SLING LIFT CARLO
MDR report key: 8623661
·
Received May 17, 2019
Report
- Report Number
- MW5086713
- Event Type
- Death
- Date Received
- May 17, 2019
- Date of Event
- May 9, 2019
- Report Date
- May 15, 2019
- Manufacturer
- BEKA HOSPITEC / HARBOR MEDICAL INC.
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- 501
Narratives
Description of Event or Problem · 1
RESIDENT WAS BEING TRANSFERRED WITH BEKA CARLO COMFORT MECHANICAL LIFT WHEN ASSEMBLY BAR SUDDENLY BROKE CAUSING RESIDENT TO FALL TO GROUND LANDING ON HER BOTTOM. SHE WAS HOSPITALIZED AS SHE STARTED TO HAVE A CHANGE IN CONDITION WHERE LATER WE WERE INFORMED BY HOSPITAL THAT SHE HAD EXPIRED. AT THIS TIME WE ARE TOLD BY CORONER'S OFFICE THAT THE RESIDENT DID NOT EXPERIENCE AN INJURY RELATED SPECIFICALLY TO THE FALL. AT THIS TIME DEATH CERTIFICATE IS PENDING AS THEY ARE WAITING ON CULTURES. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 415547 | BEKA HOSPITEC SLING LIFT CARLO | LIFT, PATIENT, NON-AC-POWERED | FSA | BEKA HOSPITEC / HARBOR MEDICAL INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Death| H |