MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for AIRLIFE 2074816-001 manufactured by Carefusion Finland 320 Oy.
[122368446]
When the nurse was repositioning the temperature probe cover she lifted off the cover (hydrogel heart) and discovered the temperature probe sensor imbedded into the skin of a neonate. A 1x2 wound noted with broken skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7926501 |
| MDR Report Key | 7926501 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-25 |
| Date of Event | 2018-08-04 |
| Report Date | 2018-09-25 |
| Date Reported to FDA | 2018-09-25 |
| Date Reported to Mfgr | 2018-10-02 |
| Date Added to Maude | 2018-10-02 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | AIRLIFE |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2018-10-02 |
| Model Number | 2074816-001 |
| Catalog Number | 2074816-001 |
| Lot Number | AAS171204 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION FINLAND 320 OY |
| Manufacturer Address | 10020 PACIFIC MESA BLVD. SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-02 |