MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-07 for HILL-ROM/ AIRSHIELDS-DRAGER C2HS-1 SERIES 03 manufactured by Draeger Medical System, Inc..
[110716663]
Infant in isolette for phototherapy. Had been active in the bed needing re-positioning. Apparently fell through porthole of isolette to floor. Unwitnessed by rn. This porthole had not been opened during patient cares at all.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077691 |
| MDR Report Key | 7582139 |
| Date Received | 2018-06-07 |
| Date of Report | 2018-06-05 |
| Date of Event | 2018-05-24 |
| Date Added to Maude | 2018-06-08 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HILL-ROM/ AIRSHIELDS-DRAGER |
| Generic Name | ISOLETTE |
| Product Code | FMZ |
| Date Received | 2018-06-07 |
| Model Number | C2HS-1 |
| Catalog Number | SERIES 03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRAEGER MEDICAL SYSTEM, INC. |
| Manufacturer Address | TELEFORD PA 18969 US 18969 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-07 |