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 EVITA XL 8419600 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[185972932]
For the investigation the given information were analysed. It was assumed that due to a faulty non-return valve the evita xl performed one or several warmstarts in order to solve the detected problem. I such a case the evita xl alerts the user several times about the ventilation situation. As a safety feature of the ventilator, the ventilator software analyzes and verifies proper function of the device. It is likely that the ventilator software detected an internal failure. The user would be alerted to this condition by an audible alarm and a visual message would be posted in the display. The ventilator may attempt a warmstart (to re-boot). An audible alarm would be posted by the device and when the warm start occurs, the device will briefly power off and then back on. During this time, an emergency-breathing valve would open allowing for spontaneous breathing. In the event of an unsuccessful warm start, a continuous audible alarm would be activated, and the emergency-breathing valve would remain open allowing for spontaneous breathing. Manual ventilation with an alternate device may be considered necessary. (remark: a single successful warmstart lasts approximately 8 seconds. ) the evita xl was repaired on site by replacing the suspected non-return valve. It remains unclear, which non-return valve exactly was replaced. However, no further problems were reported up to now. It reacted as specified for this failure condition.
Patient Sequence No: 1, Text Type: N, H10
[185972933]
It was reported that the unit was alarming vent inop. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2020-00108 |
| MDR Report Key | 9907652 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2020-03-04 |
| 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 | EVITA XL |
| Generic Name | VENTILATORS, INTENSIVE CARE |
| Product Code | CBK |
| Date Received | 2020-03-31 |
| Model Number | NA |
| Catalog Number | 8419600 |
| 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 | 2020-03-31 |