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 PRIMUS 8603800 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[186751873]
The responsible dr? Ger service engineer could confirm the reported issue during on-site checking and trace it back to the ventilator motor. The entire motor assembly was replaced, consequently. The log file demonstrates that the device forced a shutdown of automatic ventilation due to a detected wrong motor position. The motor speed is monitored continuously; speed fluctuations caused e. G. By an abraded collector disc will result in a deviation between measured and expected piston position. To prevent from damages, the system is designed to shut down automatic ventilation and to alert the user by means of a corresponding alarm. Manual ventilation and the monitoring functions remain available to the full extent. Dr? Ger finally concludes that the device behaved as specified upon the malfunction of a single component; no patient consequences have been reported. The repair exchange of the motor unit has fully solved the device problem. The motor is designed for a lifetime of 10 years at standard use conditions. The respective unit was produced in 12/2008; it can be considered that it has lasted for the expected runtime. 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
[186751874]
It was reported that the device had a ventilator failure during use. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2020-00107 |
| MDR Report Key | 9906743 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2008-12-31 |
| 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 | PRIMUS |
| Generic Name | ANESTHESIA UNITS |
| Product Code | BSZ |
| Date Received | 2020-03-31 |
| Model Number | NA |
| Catalog Number | 8603800 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-31 |