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 2014-10-14 for BLUE 30 BLUE30 S 55002093S manufactured by Maquet Sas.
[5101702]
The customer reported to maquet that a bulb exploded and caused glass splinters falling on the operating area during an ambulatory surgery. No injuries were reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12292472]
For a similar event, maquet (b)(4) contacted the supplier of the halogen bulbs for assistance. The supplier reported they test 100% of the bulbs in a vacuum oven in order to reduce risks of bursting. Continued use of lamp beyond stated bulb life, and overvoltage or a weakness of the bulb's glass caused by contaminate (e. G. Fingerprint) can lead to the type of failure reported. The device has been repaired by the hospital.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710055-2014-00084 |
| MDR Report Key | 4177054 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-10-14 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-08-28 |
| Date Mfgr Received | 2014-09-15 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2014-10-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON, ORLEANS CEDEX 2 45074 |
| Manufacturer Country | FR |
| Manufacturer Postal | 45074 |
| Manufacturer Phone | 9737097753 |
| 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 | 2014-10-14 |
| Model Number | BLUE30 S |
| Catalog Number | 55002093S |
| Lot Number | NA |
| ID Number | 56077460 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | ORLEANS FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-14 |