MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-12 for ALPHAMAQUET OPERATING TABLE COLUMN 115001A0 manufactured by Maquet Cardiopulmonary Gmbh.
[188645292]
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
[188645293]
It was reported that the operating table failed during a surgery. The surgery was interrupted due the failure. The patient was transferred to another table and the surgery continued in another room. The patient was anesthetized when this issue occurred. A doctor of this clinic stated that the patient was harmed due to this issue. Further information concerning this harm was requested, but not provided yet. We do not know, whether a medical intervention was required to prevent a serious injury (e. G. Due to a temporal threat) or of what extent the reported harm was. That is why we report this as serious injury in abundance of caution. Manufactuerer reference # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3013876692-2020-00016 |
| MDR Report Key | 9824241 |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-17 |
| Date Facility Aware | 2020-03-12 |
| Report Date | 2020-03-12 |
| Date Reported to FDA | 2020-03-12 |
| Date Reported to Mfgr | 2020-03-12 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHAMAQUET OPERATING TABLE COLUMN |
| Generic Name | TABLE, OPERATING-ROOM, AC-POWERED |
| Product Code | FQO |
| Date Received | 2020-03-12 |
| Model Number | 115001A0 |
| Catalog Number | 115001A0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 20 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY GMBH |
| Manufacturer Address | NEUE ROTTENBURGER STRASSE 37 HECHINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-12 |