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 2020-01-10 for EXTENSION TABLE TOP 114020AN manufactured by Maquet Gmbh.
[174470164]
At the time of this report the investigation is still ongoing. As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to the fda.
Patient Sequence No: 1, Text Type: N, H10
[174470165]
It was reported that a patient died. Further information concerning the course of the event and relation to the device was requested but not yet received. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010652-2020-00001 |
| MDR Report Key | 9574232 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-10 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-02 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2007-05-15 |
| Date Added to Maude | 2020-01-10 |
| 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 Street | MAQUET GMBH KEHLER STRASSE 31, |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer G1 | HOLGER ULLRICH |
| Manufacturer Street | MAQUET GMBH KEHLER STRASSE 31, |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTENSION TABLE TOP |
| Generic Name | TABLE, OPERATING-ROOM, AC-POWERED |
| Product Code | FQO |
| Date Received | 2020-01-10 |
| Model Number | 114020AN |
| Catalog Number | 114020AN |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET GMBH |
| Manufacturer Address | KEHLER STRASSE 31 RASTATT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 2020-01-10 |