FDA Adverse Event
Death
Summary report: N
TOTALCARE
MDR report key: 1908887
·
Received November 19, 2010
Report
- Report Number
- 1824206-2010-40945
- Event Type
- Death
- Date Received
- November 19, 2010
- Date of Event
- October 25, 2010
- Report Date
- October 26, 2010
- Manufacturer
- HILL-ROM INC.
- Product Code
- FNL
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE CPR LINKAGE WAS OUT OF ADJUSTMENT. THE TECHNICIAN ADJUSTED THE CPR LINKAGE TO REPAIR THE BED.
Description of Event or Problem · 1
INFO RECEIVED INDICATES THAT A PT CODED IN THE BED WHEN THE CPR WAS USED. IT TOOK APPROXIMATELY 22 SECONDS TO LOWER THE HEAD SECTION BEFORE THE STAFF COULD ADMINISTER CPR. THE PT DID EXPIRE, BUT IT CANNOT BE DETERMINED IF THE HEAD SECTION LOWERING SLOWLY HAD ANY IMPACT ON THE PATIENT'S OUTCOME. THE BED WAS LOCATED IN (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | AC-POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |