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 2020-02-28 for HUDSON AQUATHERM HEATER 091 048-91 manufactured by Teleflex Medical.
[181974126]
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A verification of failure mode reported in the current manufacturing process was conducted as follows: 8 devices were taken from the current production, the samples were functionally inspected, and during the test the issue reported was not observed in the current manufacturing process. Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature. If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Patient Sequence No: 1, Text Type: N, H10
[181974127]
Customer reported moisture was building up in the device. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2020-00226 |
| MDR Report Key | 9770821 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-26 |
| Date Added to Maude | 2020-02-28 |
| 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 | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUDSON AQUATHERM HEATER 091 |
| Generic Name | HEATER, BREATHING SYSTEM W/WO |
| Product Code | BZE |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-03-04 |
| Catalog Number | 048-91 |
| 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 | MORRISVILLE NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |