FDA Adverse Event
Other
Summary report: N
MAXI SKY 600
MDR report key: 1943697
·
Received December 15, 2010
Report
- Report Number
- 9681684-2010-00057
- Event Type
- Other
- Date Received
- December 15, 2010
- Date of Event
- November 14, 2010
- Report Date
- November 15, 2010
- Manufacturer
- BHM MEDICAL, INC.
- Product Code
- FSA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFORMATION WILL BE PROVIDED UPON MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
DURING NIGHT ROUNDS, THE NURSE ENTERED THE ROOM TO DISCOVER THE RESIDENT'S BED WAS TIPPED OVER WITH RESIDENT AGAINST THE FAR WALL. THE MAXISKY IN THE ROOM HAD A BENT HANGER BAR AS A RESULT OF THIS INCIDENT. THERE WERE NO WITNESSES TO EXPLAIN WHAT HAPPENED AND THE RESIDENT CANNOT REMEMBER ANYTHING ABOUT THE INCIDENT DUE TO THEIR CONDITION. RESIDENT WAS BROUGHT TO HOSPITAL, TREATED FOR A MINOR ARM INJURY (NO FRACTURE REPORTED), AND THEN RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXI SKY 600 | LIFT, PATIENT, NON AC POWERED | FSA | BHM MEDICAL, INC. | LD10011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |