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 SAVINA SYSTEM 8414450 manufactured by Draegerwerk Ag & Co. Kgaa.
[185967169]
During internal review it was determined that the case would have been reportable. The provided log files were analyzed. The reported device failure alarm could be confirmed. Error code 99. 0370 (was logged two times and) indicates that the automatic calibration of the o2 control system recognized an interference. The calibration of the o2 sensors occured too often. The security software of the front processor recognizes the failure and performed a restart of the device in order to restore a valid data base, as specified for this kind of deviation. In this case, the pneumatic system opens which reduces airway pressure to ambient pressure and spontaneous breathing is possible for the patient. This system-reset is combined with an audible and visible alarm of high priority. After approximately 12 seconds the savina continued ventilation with the latest settings. The pcb control and the pcb o2 sensor went through a 125 hours test in a savina without any failures, the issue could not be duplicated. Both the pcb control and the pcb o2 were replaced. The device behaved as specified and restarted in order to solve the problem. The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Patient Sequence No: 1, Text Type: N, H10
[185967170]
The device posted device failure "99. 0370" while in use. The customer replaced the device. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2020-00109 |
| MDR Report Key | 9907746 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2017-10-30 |
| Device Manufacturer Date | 2015-11-30 |
| 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 | DRAEGERWERK AG & CO. KGAA |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | L |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAVINA SYSTEM |
| Generic Name | VENTILATORS, INTENSIVE CARE |
| Product Code | CBK |
| Date Received | 2020-03-31 |
| Model Number | NA |
| Catalog Number | 8414450 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGERWERK AG & CO. KGAA |
| Manufacturer Address | MOISLINGER ALLEE 53-55 L?BECK GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |