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 2020-03-26 for FABIUS GS manufactured by Dr?gerwerk Ag & Co. Kgaa.
[185115702]
The particular device is not under service contract. The hospital's biomed reported some error codes she found in the log. These codes indicate that there was a problem with the ventilator motor and/or the piston position detection system. It is plausible that such error condition was the root cause for the shutdown of the ventilation. The motor speed is being monitored continuously; speed fluctuations caused e. G. By an abraded collector disc will result in a deviation between measured and expected piston position. An error in the piston position detection system (light barrier, dedicated cable and control unit) will also have the effect that the software can't prove the correct piston position anymore. To prevent from damages to the ventilator system the device shuts down automatic ventilation and alerts the user to this condition by means of a corresponding alarm. Manual ventilation and the monitoring functions remain available to the full extent. The exact nature of the failure condition could not be determine due to lack of information. The biomed has received all details from dr? Ger technical support to rectify the problem. The device is 16 years old, a wear-and-tear related malfunction after such a long time of use would not be unexpected. The number of similar cases is within the expected range of the respective risk assessment and thus accepted.
Patient Sequence No: 1, Text Type: N, H10
[185115703]
It was reported that there was a ventilator failure. It was mentioned that this did not lead to any injury of the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2020-00098 |
| MDR Report Key | 9885275 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-22 |
| Date Mfgr Received | 2020-03-16 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Generic Name | ANESTHESIA UNITS |
| Product Code | BSZ |
| Date Received | 2020-03-26 |
| Model Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-26 |