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 2019-01-17 for VENTSTAR HELIX MP02607 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[133326872]
The investigation has just started; results will be provided in a follow up-report.
Patient Sequence No: 1, Text Type: N, H10
[133326873]
It was reported that a crack was found in the breathing circuit. The patient developed desaturation followed by bradycardia and cardiac arrest. Cpr was done and patient revived.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611500-2019-00014 |
| MDR Report Key | 8256214 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-01-17 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-01-04 |
| Date Mfgr Received | 2019-05-08 |
| Date Added to Maude | 2019-01-17 |
| 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 | 3 |
| Brand Name | VENTSTAR HELIX |
| Generic Name | BREATHING HOSE, DISPOSABLE |
| Product Code | BTC |
| Date Received | 2019-01-17 |
| Model Number | NA |
| Catalog Number | MP02607 |
| 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 | 1. Life Threatening | 2019-01-17 |