FDA Adverse Event
Malfunction
Summary report: N
MAXISKY 1000
MDR report key: 2104981
·
Received February 22, 2011
Report
- Report Number
- 9681684-2011-00016
- Event Type
- Malfunction
- Date Received
- February 22, 2011
- Date of Event
- January 21, 2010
- Report Date
- January 28, 2010
- Manufacturer
- BHM MEDICAL, INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS, THIS WAS FOUND TO BE A REPORTABLE EVENT. FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
PER THE ARJOHUNTLEIGH SERVICE TECH COMMENTS: "PATIENT WAS SITTING IN CHAIR. THEN PATIENT NOTICED THE LIFT WAS SMOKING. PATIENT CALLED THE NURSE WHO THEN PULLED THE FIRE ALARM. MAINTENANCE WENT UP AND TOOK DOWN THE LIFT. THE UNIT SMOKED ENOUGH TO FILL UP A 20 X 20 FOOT ROOM AND PART OF THE HALLWAY. MAINTENANCE REMOVED FROM SERVICE FOR INSPECTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXISKY 1000 | MANUFACTURED CEILING FIXED CASSETTES | FSA | BHM MEDICAL, INC. | LF20011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |