D
Patient 1
THE CUSTOMER REPORTED TO MAQUET A BULB EXPLODED WHILE EXAMINING A PATIENT. NO FALLING COMPONENTS NOR INJURIES WERE REPORTED. (B)(4).
MAUDE MDR 3979797
- MDR report key
- 3979797
- Report number
- 9710055-2014-00041
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-05-05
- Date received
- 2014-06-04
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 401
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JANICE PEVIDE
- Address
- 45 BARBOUR POND DRIVE WAYNE NJ 07470 US
- Phone
- 973-973-9737
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BLUE 30 | MAQUET S.A.S. | FSS | BLUE30 | 55002026C | NA | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-06-04 | 0 |
Event Narratives#
N
Patient 1
FOR A SIMILAR EVENT, MAQUET (B)(4) CONTACTED THE SUPPLIER OF THE HALOGEN BULBS FOR ASSISTANCE. THE SUPPLIER REPORTED THAT THEY TEST 100% OF THE BULBS IN A VACUUM OVEN IN ORDER TO REDUCE RISKS OF BURSTING. CONTINUED USE OF A LAMP BEYOND STATED BULB LIFE, AN OVERVOLTAGE OR A WEAKNESS OF THE BULB'S GLASS CAUSED BY CONTAMINATE (E.G. FINGERPRINT) CAN LEAD TO THE TYPE OF FAILURE REPORTED. THE BLUE 30/80 SERIES OPERATING MANUAL INCLUDES THE FOLLOWING INSTRUCTION FOR USERS: 4.1 REPLACING THE LIGHT BULB ATTENTION: DO NOT TOUCH THE GLASS BODY OF THE HALOGEN BULB WITH BARE FINGERS. REPLACE THE BULB EVERY 600 HOURS. A MAQUET TECH REPLACED THE BULB WITH A NEW ONE AND RETURNED THE DEVICE TO SERVICE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.