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 2019-01-04 for AIRLIFE 2K8040 manufactured by Vyaire Medical.
[132113411]
At this time, vyaire has not received the sample for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[132113412]
The customer reported the airlife infant manual resuscitator are falling apart during a code. The customer reported an alternative manual resuscitator was found and used. The customer reported there is no patient consequence associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2019-00021 |
| MDR Report Key | 8218324 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-04 |
| Date of Report | 2018-12-13 |
| Date of Event | 2018-12-13 |
| Date Mfgr Received | 2018-12-13 |
| Date Added to Maude | 2019-01-04 |
| 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 | 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 | PRODUCTOS UR |
| Manufacturer Street | CERRADA V 85 PARQUE UNDUSTRIAL MEX III |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2019-01-04 |
| Model Number | 2K8040 |
| Catalog Number | 2K8040 |
| Lot Number | 0001143879 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Required No Informationntervention | 2019-01-04 |