MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-05 for AIR-VAC TRANSPORT INCUBATOR manufactured by Ohmeda.
[17442064]
Inside the incubator's plexiglass hood, there is a thermometer in a thermometer holder which is glued to the hood. The holder becomes ungluded and falls into the incubator. Recently, there were 2 incidents where the thermometer barely missed infants. The reporter notified the mfr of the probelm as far back as 3 yrs ago. Since 1987, there have been 21 incidents; 4 reports were made to the mfr. This info was submitted as f/u 3/10/94: another incident occured on 3/4/94.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000299 |
| MDR Report Key | 10790 |
| Date Received | 1994-01-05 |
| Date of Report | 1994-01-04 |
| Date Added to Maude | 1994-01-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIR-VAC TRANSPORT INCUBATOR |
| Product Code | FPL |
| Date Received | 1994-01-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10790 |
| Manufacturer | OHMEDA |
| Manufacturer Address | MADISON WI 537077550 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-05 |