MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-05 for HANAULUX 2000 HM58000308 manufactured by Maquet Sas.
[178202123]
Issue is being investigated by manufacturer. Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[178202124]
On (b)(6) 2019 getinge became aware of issue occurring on the market with hanaulux surgical lamp. In the complaint at hand it was reported that screw has fall off the device during operation and touched the patient. There is no information about any injury or any other negative outcome for patient due to claimed issue, however, we decided to report the issue based on the potential and any particles falling off into sterile field or during procedure may cause contamination risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710055-2019-00343 |
| MDR Report Key | 9415391 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-12-05 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-19 |
| Date Added to Maude | 2019-12-05 |
| 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 | MR. PASCAL JAY |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Manufacturer G1 | MAQUET SAS |
| Manufacturer Street | PARC DE LIMERE AVENUE DE LA POMME DE PIN |
| Manufacturer City | ARDON |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANAULUX 2000 |
| Generic Name | LAMP, SURGICAL |
| Product Code | FTD |
| Date Received | 2019-12-05 |
| Catalog Number | HM58000308 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET SAS |
| Manufacturer Address | PARC DE LIMERE AVENUE DE LA POMME DE PIN ARDON US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-05 |