MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-21 for AGILA G16805-40 manufactured by Dr?gerwerk Ag & Co. Kgaa.
[175632886]
The investigation has just started; results will be provided in a follow up-report.
Patient Sequence No: 1, Text Type: N, H10
[175632887]
It was reported that there was fire incident in the picu. The agila was all burned. There was no person at that moment, so no injury reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9611500-2020-00016 |
MDR Report Key | 9609398 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2020-01-21 |
Date of Report | 2020-01-20 |
Date of Event | 2019-12-17 |
Date Mfgr Received | 2019-12-24 |
Device Manufacturer Date | 2011-10-31 |
Date Added to Maude | 2020-01-21 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 0 |
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 | AGILA |
Generic Name | MEDICAL GAS AND VACUUM SYSTEMS |
Product Code | FQO |
Date Received | 2020-01-21 |
Model Number | NA |
Catalog Number | G16805-40 |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
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 | 2020-01-21 |