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 2020-03-18 for VENTSTAR ANESTHESIA MP00372 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[186770304]
The investigation is still on-going. The results will be provided within a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[186770305]
It was reported that when using the breathing circuits the blue connector detaches from the tube- this also affects the bag tube. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2020-00082 |
| MDR Report Key | 9846826 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-18 |
| 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 | VENTSTAR ANESTHESIA |
| Generic Name | BREATHING HOSE, DISPOSABLE |
| Product Code | CAI |
| Date Received | 2020-03-18 |
| Catalog Number | MP00372 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2020-03-18 |