MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2015-04-06 for HEATED CIRCUIT MEDICAL UNKNOWN manufactured by Teleflex Medical.
[5728439]
The customer alleges that the heated circuit burnt when the concha neptune overheated. The patient's condition is reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[13180742]
(b)(4). It is unknown if the device sample is available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004365956-2015-00117 |
| MDR Report Key | 4665171 |
| Report Source | 06,07 |
| Date Received | 2015-04-06 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-02-24 |
| Date Mfgr Received | 2015-03-19 |
| Date Added to Maude | 2015-05-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| 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 | HEATED CIRCUIT |
| Generic Name | BREAHTING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-04-06 |
| Catalog Number | MEDICAL UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-06 |