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 OXYLOG 3000 2M86955 manufactured by Draegerwerk Ag & Co. Kgaa.
[185710558]
For the investigation the provided information was analysed. As the logfiles were not available, it was not possible to retrace the described warmstart. In general the device alarms visually and acoustically in case of a technical problem (e. G. Warm start). In this case an alternative independent ventilation device has to be used instantly, as described in the ifu. The service engineer on site replaced the battery and inspected the contacts visually, nothing suspect could be identified. Based on the available information, finding a specific root cause for the reported warm start was not possible.
Patient Sequence No: 1, Text Type: N, H10
[185710559]
It was reported that the device performed a warmstart during transfer. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2020-00102 |
| MDR Report Key | 9902282 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2009-06-30 |
| 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 | OXYLOG 3000 |
| Generic Name | VENTILATORS, TRANSPORT |
| Product Code | CBK |
| Date Received | 2020-03-31 |
| Model Number | NA |
| Catalog Number | 2M86955 |
| 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 |