MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-01-17 for BLUE 30 BLUE30SW 55002095C manufactured by Maquet Sas.
[4234110]
The customer reported to maquet that a bulb of a blue 30 burst during use, and caused glass splinters to fall onto a neonate patient. No injuries were reported to maquet. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11583922]
The customer has removed the device from service. Maquet has not been informed if or when the device will be repaired. 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, an overvoltage of a weakness of the bulb's glass caused by contaminate (e. G. Fingerprint) can lead to the type of failure reported. The blue (b)(4) 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. Should additional information become available, a follow up report will be submitted. Maquet medical systems usa submits this report on behalf of the device manufacturing facility. Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710055-2014-00007 |
| MDR Report Key | 3704390 |
| Report Source | 01,05,07 |
| Date Received | 2014-01-17 |
| Date of Report | 2013-12-30 |
| Date of Event | 2013-12-27 |
| Date Facility Aware | 2014-01-02 |
| Report Date | 2014-01-20 |
| Date Mfgr Received | 2013-12-30 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2014-04-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS JANICE PEVIDE |
| Manufacturer Street | 45 BARBOUR POND DR. |
| Manufacturer City | WAYNE NJ 07470 |
| Manufacturer Country | US |
| Manufacturer Postal | 07470 |
| Manufacturer Phone | 9737097753 |
| Manufacturer G1 | MAQUET SAS |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLUE 30 |
| Product Code | FSS |
| Date Received | 2014-01-17 |
| Model Number | BLUE30SW |
| Catalog Number | 55002095C |
| Lot Number | NA |
| ID Number | 56077460 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 90 MO |
| 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 | 2014-01-17 |