MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-31 for FABIUS GS PREMIUM 8607000 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[185658069]
The investigation was started; the results will be provided in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[185658070]
It was initially reported, that the customer complained because the device did not offer o2 to the patient, leading to hypoxia. Further information was received 2020-03-30: the customer reported that the hypoxia led to bradycardia and to crp. It was further reported that the patient died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2020-00104 |
| MDR Report Key | 9902380 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-25 |
| Device Manufacturer Date | 2009-01-31 |
| Date Added to Maude | 2020-03-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer G1 | DR |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | L 23542 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 23542 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FABIUS GS PREMIUM |
| Generic Name | ANESTHESA UNITS |
| Product Code | BSZ |
| Date Received | 2020-03-31 |
| Model Number | NA |
| Catalog Number | 8607000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DR?GERWERK AG & CO. KGAA |
| Manufacturer Address | MOISLINGER ALLEE 53-55 L?BECK 23542 GM 23542 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-31 |