MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-04 for INCUBATOR 8000 IC 8000 IC UNKNOWN manufactured by Dragerwerk Ag.
[7472]
It was reported that: the heater of the incubator had stopped during operation with a patient. The display for the temperature showed dashes w/o acoustical alarm. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 49340-1994-00002 |
| MDR Report Key | 11881 |
| Date Received | 1994-03-04 |
| Date of Report | 1994-02-08 |
| Date of Event | 1994-02-03 |
| Report Date | 1994-02-09 |
| Date Added to Maude | 1994-03-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INCUBATOR 8000 IC |
| Generic Name | INCUBATOR |
| Product Code | JTQ |
| Date Received | 1994-03-04 |
| Model Number | 8000 IC |
| Catalog Number | UNKNOWN |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11881 |
| Manufacturer | DRAGERWERK AG |
| Manufacturer Address | 23 542 LUBECK GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-04 |