FDA Adverse Event
Malfunction
Summary report: N
MAXISKY 600
MDR report key: 2111024
·
Received May 24, 2011
Report
- Report Number
- 9681684-2011-00040
- Event Type
- Malfunction
- Date Received
- May 24, 2011
- Date of Event
- April 24, 2011
- Report Date
- April 26, 2011
- Manufacturer
- BHM MEDICAL, INC.
- Product Code
- FNG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER IS AWAITING RETURN OF THE DEFECTIVE PART. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
THE HUSBAND WAS PREPARING THE TRANSFER OF HIS WIFE WHO WAS LYING IN HER BED. THE CEILING LIFT WAS MADE READY AND TURNED ON. THE SPREADER BAR BEGAN TO LOWER NORMALLY, THEN THE CEILING LIFT MADE A STRANGE NOISE AND THE STRAP AND SPREADER BAR MADE A DROP OF MORE THAN 5 FEET, ON TOP OF THE PATIENT. SHE SUSTAINED SOME BRUISES ON ARM, CHEST AND HIPS, BUT NO TREATMENT WAS REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXISKY 600 | MANUFACTURED CEILING FIXED CASSETTES | FNG | BHM MEDICAL, INC. | LD10000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |