MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2003-11-24 for TI500 GLOBETROTTER * manufactured by Hill-rom Airshields.
[295416]
Incident was filed in regards to this globetrotter unit. He is reporting that during the transport of a pt the flow of the o2 stopped during the transport and the pt required immediate care when they arrived at the icu. No injury is being reported. The customer is alleging that they have replaced the flow valve p/n 6736249 several times due to problems with the knob binding. 2003 tsr on site. Found that starting from off and selecting low flows up to 6 lpm, there is no flow. At 6 lpm the flowmeter starts delivering gas. When lower down to 1/2 lpm the flow control seems to function. This is the 3rd time the flow control has been replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2510954-2003-00008 |
| MDR Report Key | 498623 |
| Report Source | 00 |
| Date Received | 2003-11-24 |
| Date of Report | 2003-11-21 |
| Date of Event | 2003-10-21 |
| Date Mfgr Received | 2003-10-21 |
| Device Manufacturer Date | 2001-11-01 |
| Date Added to Maude | 2003-12-03 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MONICA FERRANTE |
| Manufacturer Street | 330 JACKSONVILLE RD |
| Manufacturer City | HATBORO PA 19040 |
| Manufacturer Country | US |
| Manufacturer Postal | 19040 |
| Manufacturer Phone | 2156828691 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI500 GLOBETROTTER |
| Generic Name | TRANSPORT INCUBATOR |
| Product Code | FPL |
| Date Received | 2003-11-24 |
| Model Number | TI500 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 487371 |
| Manufacturer | HILL-ROM AIRSHIELDS |
| Manufacturer Address | 330 JACKSONVILLE RD. HATBORO PA 19040 US |
| Baseline Brand Name | TI500 GLOBETROTTER |
| Baseline Generic Name | TRANSPORT INCUBATOR |
| Baseline Model No | TI500 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-11-24 |