MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-06-04 for BLUE 30 BLUE30 55002026C manufactured by Maquet S.a.s..
[17263476]
The customer reported to maquet a bulb exploded while examining a patient. No falling components nor injuries were reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[17453572]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710055-2014-00041 |
| MDR Report Key | 3979797 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-06-04 |
| Date of Report | 2014-05-06 |
| Date of Event | 2014-05-05 |
| Date Facility Aware | 2014-05-15 |
| Report Date | 2014-06-04 |
| Date Mfgr Received | 2014-05-06 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2014-08-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DRIVE |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET S.A.S. |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON, ORLEANS CEDEX 2 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 45074 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLUE 30 |
| Product Code | FSS |
| Date Received | 2014-06-04 |
| Model Number | BLUE30 |
| Catalog Number | 55002026C |
| Lot Number | NA |
| ID Number | 56077851 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET S.A.S. |
| Manufacturer Address | ORLEANS FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-04 |