MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-30 for ROADRUNNER TI 100 manufactured by Air-shields Vickers, Inc..
[15484734]
During transport, dc power was lost. Of the four clips on the two batteries, three clips wre found to be disconnected. Rptr found that the clips' opening had widened and loosened. Rptr checked two other incubators and found that all the clips on one were very loose and offered no resistance to removal. Rptr believes that the clips used may be inadequate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003557 |
| MDR Report Key | 16532 |
| Date Received | 1994-09-30 |
| Date of Report | 1994-09-23 |
| Date of Event | 1994-06-01 |
| Date Added to Maude | 1994-10-03 |
| 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 | ROADRUNNER |
| Generic Name | TRANSPORT INCUBATOR |
| Product Code | FPL |
| Date Received | 1994-09-30 |
| Model Number | TI 100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16465 |
| Manufacturer | AIR-SHIELDS VICKERS, INC. |
| Manufacturer Address | HATBORO PA 19040 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-09-30 |