MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-03-26 for HUDSON DISP MANUAL RESUS,ADULT W/FLOW DIVERTER 5372 manufactured by Teleflex Medical.
[139825471]
(b)(4). The device involved has been returned to the manufacturer for evaluation, however the evaluation of said device has not been completed at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[139825472]
Customer complaint reported: "when resuscitation bag was used on patient, health care provider found difficulty with ventilation & exhalation (was able to exhale but it was prolonged). Provider examined the resuscitation set and found that 15 mm connector that attaches to the ett, pushes the duck valve making it difficult to inspire and exhale. " no patient harm reported. Patient condition reported as fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2019-00073 |
| MDR Report Key | 8451577 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-04 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-04-22 |
| Date Added to Maude | 2019-03-26 |
| 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/FLOW DIVERTER |
| Generic Name | VENTILATOR, EMERGENCY, MANUAL |
| Product Code | BTM |
| Date Received | 2019-03-26 |
| Returned To Mfg | 2019-03-12 |
| Catalog Number | 5372 |
| Lot Number | 180611 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-26 |