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 2019-08-19 for HUDSON DUAL HEATED DUAL DRAIN 880-36KIT manufactured by Teleflex Medical.
[154795794]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[154795795]
The complaint is reported as: "new circuit. Rt started heater. After about 60 minutes (maybe less) the circuit failure alarm initiated. Rt turned heater off and restarted and heater alarmed circuit failure again. Circuit changed and heater worked. Rt saved circuit to return to teleflex. ". No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3004365956-2019-00215 |
MDR Report Key | 8907523 |
Report Source | COMPANY REPRESENTATIVE,USER F |
Date Received | 2019-08-19 |
Date of Report | 2019-08-01 |
Date of Event | 2019-07-31 |
Date Mfgr Received | 2019-08-28 |
Device Manufacturer Date | 2019-05-20 |
Date Added to Maude | 2019-08-19 |
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 | PARQUE INDUSTRIAL FINSA |
Manufacturer City | NUEVO LAREDO 88275 |
Manufacturer Country | MX |
Manufacturer Postal Code | 88275 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | HUDSON DUAL HEATED DUAL DRAIN |
Generic Name | HUMIDIFIER NEBULIZER KIT |
Product Code | OGG |
Date Received | 2019-08-19 |
Returned To Mfg | 2019-08-13 |
Catalog Number | 880-36KIT |
Lot Number | 74E1902404 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
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 | 2019-08-19 |