MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-02 for AIRFLOW ADULT RESUSCITATOR AF1140MBP-T manufactured by Ventlab, Llc., A Subsidiary Of Sunmed.
[59132409]
Air flow ambu bag tubing has kinks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065792 |
| MDR Report Key | 6078360 |
| Date Received | 2016-11-02 |
| Date of Report | 2016-10-25 |
| Date Added to Maude | 2016-11-04 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | AIRFLOW ADULT RESUSCITATOR |
| Generic Name | AMBU BAG |
| Product Code | NHK |
| Date Received | 2016-11-02 |
| Model Number | AF1140MBP-T |
| Lot Number | 306289 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VENTLAB, LLC., A SUBSIDIARY OF SUNMED |
| Manufacturer Address | 2710 NORTHRIDGE DR NW SUITE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-02 |