MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-12-11 for C100 INFANT INCUBATOR * manufactured by Hill-rom Airshields.
[298580]
This incubator had been turned off though the pt. Still there. Heating element turned off, patient temperature fell to 33. 5 degrees c before noticed. Patient rewarmed, no injury. Date of incident: 2001.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2510954-2002-00011 |
| MDR Report Key | 432994 |
| Report Source | 00 |
| Date Received | 2002-12-11 |
| Date of Report | 2002-12-06 |
| Date of Event | 2002-04-01 |
| Date Mfgr Received | 2002-11-19 |
| Date Added to Maude | 2002-12-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | M. FERRANTE |
| Manufacturer Street | 330 JACKSONVILLE ROAD |
| Manufacturer City | HATBORO PA 19040 |
| Manufacturer Country | US |
| Manufacturer Postal | 19040 |
| Manufacturer Phone | 2516828691 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C100 INFANT INCUBATOR |
| Generic Name | INFANT INCUBATOR |
| Product Code | FPL |
| Date Received | 2002-12-11 |
| Model Number | C100 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 421952 |
| Manufacturer | HILL-ROM AIRSHIELDS |
| Manufacturer Address | 330 JACKSONVILLE RD. HATBORO PA 19040 US |
| Baseline Brand Name | C100 INFANT INCUBATOR |
| Baseline Generic Name | NEONATAL INFANT INCUBATOR |
| Baseline Model No | C100 |
| Baseline Catalog No | AYB1071 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-12-11 |