FDA Adverse Event
Malfunction
Summary report: N
MAXISKY 600
MDR report key: 2110990
·
Received April 29, 2011
Report
- Report Number
- 9681684-2011-00033
- Event Type
- Malfunction
- Date Received
- April 29, 2011
- Date of Event
- March 30, 2011
- Report Date
- March 31, 2011
- Manufacturer
- BHM MEDICAL INC.
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
FURTHER INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
AFTER TECHNICIAN HAD FINISHED A MAINTENANCE ON CEILING LIFT, HE NOTICED RED SERVICE LIGHT ON. HE NOTIFIED STAFF THAT DEVICE WAS NOT WORKING AND LEFT THE ROOM. SEVERAL MINS AFTER, THE STAFF NOTICED SMOKE THAT WAS COMING OUT FROM THE TOP OF THE DEVICE. THEY PULLED THE STOP CORD AND MOVED THE DEVICE AWAY FROM THE CHARGING STATION BUT SMOKE CONTINUED TO COME OUT, SO STAFF PULLED FIRE ALARM AND EVACUATED THE UNIT. AFTERWARDS, THE DEVICE BATTERIES WERE DISCONNECTED. NO INJURIES WERE SUSTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXISKY 600 | MANUFACTURED CEILING FIXED CASSETTES | FSA | BHM MEDICAL INC. | LD10001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |