MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2015-09-09 for HUDSON NEONATE DUAL HEAT 880-15KIT manufactured by Teleflex Medical.
[25275180]
(b)(4). A device history record could not be conducted since the lot number was not provided. The device sample was received by the manufacturer but the investigation is incomplete at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[25275181]
The customer alleges that the circuit was melted in two areas. The circuit was replaced. No patient injury or harm reported.
Patient Sequence No: 1, Text Type: D, B5
[26777715]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the translucent (expiratory) side of the limb displayed two areas that appear to be melted/damaged. The visual inspection also confirmed that the heated wires of the limb have not been misplaced, or "bunched" at any point in the circuit, which could cause temperatures high enough to melt the plastic tubing. The heated wires of the damaged/melted expiratory limb show no signs of damage or discoloration that might indicate the plastic insulation of the wires overheated. The damaged areas show melting taking place on top of the circuit pipe ridges which suggest the circuit limb might have come in contact with something hot from an external source instead of the internal heated wire. Based on the investigation performed, the reported complaint was confirmed. Although the complaint was confirmed, a root cause for the melted circuit could not be determined. A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
[26777716]
The customer alleges that the circuit was melted in two areas. The circuit was replaced. No patient injury or harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2015-00278 |
| MDR Report Key | 5064437 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-09-09 |
| Date of Report | 2015-08-14 |
| Date of Event | 2015-08-14 |
| Date Mfgr Received | 2015-09-16 |
| Date Added to Maude | 2015-09-09 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| 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 NEONATE DUAL HEAT |
| Generic Name | BREATHING CIRCUIT |
| Product Code | CAG |
| Date Received | 2015-09-09 |
| Returned To Mfg | 2015-08-28 |
| Catalog Number | 880-15KIT |
| 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 | 2015-09-09 |