FDA Adverse Event
Summary report: N
PANDA IRES
MDR report key: 2051950
·
Received April 6, 2011
Report
- Report Number
- 2051950
- Date Received
- April 6, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 17, 2011
- Manufacturer
- GE MEDICAL SYSTEMS
- Product Code
- FMT
- Report Source
- User Facility report
- Reporter Location
- CT, US
Narratives
Description of Event or Problem · 1
NURSING STAFF REPORTED THAT AN INFANT WAS PLACED IN ISOLETTE AND ROLLED INTO THE MOTHER'S ROOM. THE ISOLETTE WAS SET TO MANUAL MODE. A NURSE OBSERVED THAT THE INFANT WAS FINE UPON EXITING THE ROOM. AFTER FIFTEEN MINUTES THE NURSE NOTED THAT THE INFANT APPEARED TO BE VERY RED ON ONE COMPLETE SIDE.====================== MANUFACTURER RESPONSE FOR INFANT RADIANT WARMER, PANDA IRES======================OUR SALES REP HAS SCHEDULED A VISIT TO SPEAK WITH ONE OF OUR EDUCATORS IN WOMEN AND INFANTS. HE ALSO PROVIDED THE HOSPITAL WITH INFORMATION THAT CAN BE AFFIXED TO THE WARMERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PANDA IRES | ISOLETTE, INFANT | FMT | GE MEDICAL SYSTEMS | PANDA IRES | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5 DAY | NO OTHER THERAPIES |