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 2014-07-25 for HANAULUX 3000 HLX H4H5 DF V HM567823511 manufactured by Maquet S.a.s.
[18792361]
Customer reported that the surgical light cupola fell out during a surgery, hitting the operating room nurse. According to the customer, there was no major injuries to the nurse. No pt harm was reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18861142]
Note: the nanaulux 3000 series light system is not marketed in the us. This report has been submitted due to a similarity with devices marketed by maquet in the us. A maquet field service technician (fst) evaluated the device. He determined that the lighthead fell of the spring arm because the secure screw was missing and retaining ring pulled up. The hanaulux series operating manual mentions that the products are to be inspected by a specialised technician every six months. Maquet is not the primary service provider of these lights; they are maintained by the hospital biomedical staff. The device was repaired by the fst and can be reused. Maquet medical 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 | 9710055-2014-00057 |
| MDR Report Key | 4004721 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-06-25 |
| Date of Event | 2014-06-25 |
| Report Date | 2014-06-04 |
| Date Mfgr Received | 2014-06-25 |
| Device Manufacturer Date | 2009-03-01 |
| Date Added to Maude | 2014-08-25 |
| 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 | MS. 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. |
| 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 | HANAULUX 3000 |
| Generic Name | NONE |
| Product Code | FSS |
| Date Received | 2014-07-25 |
| Model Number | HLX H4H5 DF V |
| Catalog Number | HM567823511 |
| Lot Number | NA |
| ID Number | ARD567934999 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET S.A.S |
| Manufacturer Address | ARDON, ORLEANS CEDEX 2 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-07-25 |