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 2014-06-11 for ORCHIDE OHD SET 567702910C manufactured by Maquet S.a.s..
[4885979]
The hosp reported that a camera broke and detached from the light head while being manipulated by a doctor. The camera remained attached to the light head, suspended by its cables. No injuries nor adverse effects were reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12323086]
A maquet field service tech (fst) evaluated the device. He found evidence this device collided with other objects in the operating room. Repeated impacts of the device are capable of dislodging the camera. The fst replaced the camera with a new one. The orchide camera yearly maintenance program includes a verification of the condition of the plastic covers and absence of scratches. Maquet med systems usa submits this report on behalf of the device mfg 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 | 9710055-2014-00043 |
| MDR Report Key | 3987468 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-06-11 |
| Date of Report | 2014-05-16 |
| Date Facility Aware | 2014-06-11 |
| Report Date | 2014-06-11 |
| Date Mfgr Received | 2014-05-16 |
| Device Manufacturer Date | 2009-11-01 |
| Date Added to Maude | 2014-08-18 |
| 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 | 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 | ORCHIDE |
| Product Code | KQM |
| Date Received | 2014-06-11 |
| Model Number | OHD SET |
| Catalog Number | 567702910C |
| Lot Number | NA |
| ID Number | 567702904 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET S.A.S. |
| Manufacturer Address | ORLEANS FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-11 |