MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-02-27 for TI100 TRANSPORT INCUBATOR 6730070 manufactured by Hill-rom Air-shields.
[7789123]
A mfr engineer performed an eval of the device. Engineer's findings confirmed that the battery charger connector 4p1/4j1 had become overheated, which in turn caused overheating of adjacent components. A medical device safety alert was issued in 1995 notifying users of this situation. Facility indicated being aware of this notification.
Patient Sequence No: 1, Text Type: N, H10
[15261461]
It was reported that a model ti100 transport incubator was in a hallway plugged into an ac receptacle to maintain constant warmth and battery charge. The unit caught fire and was subsequently extinguished by the fire department.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2510954-1998-00002 |
| MDR Report Key | 153345 |
| Report Source | 05,06 |
| Date Received | 1998-02-27 |
| Date of Report | 1998-01-29 |
| Date Mfgr Received | 1998-01-29 |
| Device Manufacturer Date | 1985-11-01 |
| Date Added to Maude | 1998-03-03 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LARRY KRASLEY |
| Manufacturer Street | 330 JACKSONVILLE RD |
| Manufacturer City | HATBORO PA 19040 |
| Manufacturer Country | US |
| Manufacturer Postal | 19040 |
| Manufacturer Phone | 2156828688 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI100 TRANSPORT INCUBATOR |
| Generic Name | TRANSPORT INCUBATOR |
| Product Code | FPL |
| Date Received | 1998-02-27 |
| Returned To Mfg | 1998-02-01 |
| Model Number | TI100 |
| Catalog Number | 6730070 |
| Lot Number | * |
| ID Number | * |
| Operator | NOT APPLICABLE |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 149391 |
| Manufacturer | HILL-ROM AIR-SHIELDS |
| Manufacturer Address | 330 JACKSONVILLE RD. HATBORO PA 19040 US |
| Baseline Brand Name | TI100 TRANSPORT INCUBATOR |
| Baseline Generic Name | TRANSPORT INCUBATOR |
| Baseline Model No | TI100 |
| Baseline Catalog No | 6730070 |
| Baseline ID | GP00561 |
| Baseline Device Family | TRANSPORT INCUBATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K831028 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-02-27 |