MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-03-29 for HUDSON DISP MANUAL RESUS,ADULT W/MASK & PEEP V 5374 manufactured by Teleflex Medical.
[140329861]
Qn# (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140329862]
Customer complaint alleges the reservoir bag did not inflate during a patient use. No patient harm reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00098 |
| MDR Report Key | 8465161 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-29 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-03-29 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON DISP MANUAL RESUS,ADULT W/MASK & PEEP V |
| Generic Name | VENTILATOR, EMERGENCY, MANUAL |
| Product Code | BTM |
| Date Received | 2019-03-29 |
| Catalog Number | 5374 |
| Lot Number | 180625 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-29 |