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 2020-01-10 for HUDSON COMFORT FLO HUMIDIFICATION SYSTEM 2410 manufactured by Teleflex Medical.
[174514919]
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed and no relevant findings were identified. 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
[174514920]
Customer reported the device was being used on an infant when water flooded the circuit and backed up to the patient. The patient required approximately 7 minutes of ppv with 60% fi02 and 5 peep. After recovery, oxygen was increased from 5l at 28% to 5l at 45% and then titrated down over the next few days. The patient was discharged from the hospital on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2020-00016 |
| MDR Report Key | 9575092 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-12-22 |
| Date Mfgr Received | 2020-02-20 |
| Date Added to Maude | 2020-01-10 |
| 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 COMFORT FLO HUMIDIFICATION SYSTEM |
| Generic Name | HUMIDIFIER NEBULIZER KIT |
| Product Code | OGG |
| Date Received | 2020-01-10 |
| Returned To Mfg | 2020-02-04 |
| Catalog Number | 2410 |
| Lot Number | 74C1900056 |
| 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 | 1. Required No Informationntervention | 2020-01-10 |