MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for HUDSON RCI LIFESAVER ADULT MANUAL RESUSCITATOR IPN044941 5374 manufactured by Teleflex Incorporated.
[139813195]
During resuscitation efforts, right around bag valve mask did not inflate when placed around the patient's mouth, preventing a seal therefore decreasing the effectiveness of the air being pushed into the lungs. The reservoir bag did not inflate. Bag was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8451120 |
| MDR Report Key | 8451120 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-02-21 |
| Report Date | 2019-03-20 |
| Date Reported to FDA | 2019-03-20 |
| Date Reported to Mfgr | 2019-03-26 |
| Date Added to Maude | 2019-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | HUDSON RCI LIFESAVER ADULT MANUAL RESUSCITATOR |
| Generic Name | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) |
| Product Code | BTM |
| Date Received | 2019-03-26 |
| Model Number | IPN044941 |
| Catalog Number | 5374 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX INCORPORATED |
| Manufacturer Address | 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 2019-03-26 |