MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for VENTSTAR WASSERFALLE 180 MP00337 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[131146948]
The investigation is still on-going. The results will be provided within a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[131146949]
It was reported that the breathing circuit was assembled incorrectly on the part of the y-piece. All points were connected but to a closed bypass so that a ventilation and normal functionality were not possible. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2018-00409 |
| MDR Report Key | 8183631 |
| Date Received | 2018-12-20 |
| Date of Report | 2019-03-04 |
| Date Mfgr Received | 2019-02-26 |
| Date Added to Maude | 2018-12-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SONJA HILLMER |
| Manufacturer Street | MOISLINGER ALLEE 53-55 |
| Manufacturer City | L 23542 |
| Manufacturer Country | GM |
| Manufacturer Postal | 23542 |
| Manufacturer Phone | 4518822868 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VENTSTAR WASSERFALLE 180 |
| Generic Name | BREATHING HOSE DISPOSABLE |
| Product Code | BYE |
| Date Received | 2018-12-20 |
| Model Number | NA |
| Catalog Number | MP00337 |
| Lot Number | NA |
| Device Expiration Date | 2000-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-12-20 |