FDA Adverse Event
Other
Summary report: N
HOSPITAL BED
MDR report key: 2105334
·
Received May 18, 2011
Report
- Report Number
- 2182305-2011-00013
- Event Type
- Other
- Date Received
- May 18, 2011
- Date of Event
- March 25, 2011
- Report Date
- April 21, 2011
- Manufacturer
- JOERNS HEALTHCARE
- Product Code
- FNL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO MANUFACTURER, BY FACILITY; (B)(6), PER FACILITY, THE SLEEP DECK BEARINGS TO THE BACK SECTION ON A U770 BED BROKE CAUSING THE BACK SECTION TO DROP. THERE WAS A PATIENT IN THE BED WITH A CERVICAL COLLAR ON AT THE TIME OF INCIDENT. CUSTOMER STATED MINIMAL INJURY TO THE PATIENT I.E., IN A LITTLE MORE PAIN AT THIS TIME. ANOTHER CAT SCAN IN SCHEDULED. PICTURES WERE SENT BY FACILITY FOR MANUFACTURER TO REVIEW. (B)(4) WAS ENTERED TO GET BED BACK FOR EVALUATION. FACILITY WILL NOT RELEASE BED IN QUESTION SO MANUFACTURER WILL BE SENDING IN (B)(4) OUR SERVICE TEAM INTO FACILITY TO DO INSPECTION OF BED AND TAKE PICTURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HOSPITAL BED | HOSPITAL BED ELECTRIC | FNL | JOERNS HEALTHCARE | U770 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |