MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-08-13 for AIRLIFE? INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE?, PANDA?) 2075796-001 manufactured by Vyaire Medical.
[116960638]
At this time, vyaire has not received the suspect device/component for evaluation. If additional information is received a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[116960639]
Customer reported that new temp probes are affecting the ability of the incubators at thermal regulation; while the temp probe is attached to the patient, the inflexibility of the cable causes it to lift off of the patient's skin even when covered with the appropriate heat reflecting patch; once the probe has lifted away from the skin the giraffe omnibed receives an inaccurate temp and tries to compensate by increasing the temperature in the bed. This in turn overheats the infant which then takes some time for the infant to recover this incidence. The area of the cable closest to the temp probe is stiff and rigid.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005934741-2018-00001 |
| MDR Report Key | 7778834 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-08-13 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-08-13 |
| 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 | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | THERMOMETRICS DE MEXICO S.A. DE C.V |
| Manufacturer Street | CALLE SIETE NORTE NO 110 CIUDAD INDUSTRIAL OTAY |
| Manufacturer City | TIJUANA, 22444 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22444 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE? INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE?, PANDA?) |
| Generic Name | CLINICAL ELECTRONIC THERMOMETER |
| Product Code | FMZ |
| Date Received | 2018-08-13 |
| Catalog Number | 2075796-001 |
| Lot Number | THM180404 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-13 |