MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-11-08 for AIRLIFE? INFANT SKIN TEMPERATURE PROBE, SINGLE PATIENT USE (GIRAFFE?, PANDA?) 2074816-001 manufactured by Vyaire Medical.
[126517178]
Vyaire complaint (b)(4): any additional information provided by the customer will be included in a follow-up report. At this time, vyaire has not received the suspect device/component for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[126517179]
It was reported to vyaire that a nurse was repositioning the temperature-probe cover, she lifted off the cover (hydrogel heart) and discovered that the temperature probe sensor had embedded into the skin of a neonate. The infant was reported to have sustained a skin tear. Area of erythema 0. 5cm x0. 5 cm noted over right mid abdomen due to temp probe burn; placed hydrogel dressing over the area and lesion is improving, no jaundice.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012348048-2018-00001 |
| MDR Report Key | 8050651 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-11-08 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-08-31 |
| Date Mfgr Received | 2018-10-11 |
| Date Added to Maude | 2018-11-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | AMPHENOL (CHANGZHOU) CONNECTOR SYSTEMS CO., LTD. |
| Manufacturer Street | NO. 8 XIHU ROADWUJIN HI THE DEVELOPMENT ZONE CHANGZHOU |
| Manufacturer City | JIANGSU, 213164 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 213164 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE? INFANT SKIN TEMPERATURE PROBE, SINGLE PATIENT USE (GIRAFFE?, PANDA?) |
| Generic Name | INCUBATOR, NEONATAL |
| Product Code | FMZ |
| Date Received | 2018-11-08 |
| Catalog Number | 2074816-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-08 |