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 2019-09-17 for HUDSON COMFORT FLO HUMIDIFICATION SYSTEM 2410 manufactured by Teleflex Medical.
[158817753]
(b)(4). A device history record review was performed and no relevant findings were identified. Received one (1) 2410 comfort flo humidification system for investigation. The set included one concha smart column, one single limb heated wire circuit, one pressure relief valve, infant nasal cannula, and various support brackets and air tubing. The various parts were visually inspected for any signs of abuse/misuse/damage. Nothing noted. The following tests were performed: the concha smart column was placed into an active (heated) test neptune in order to determine if the low water indicator float was working properly in the concha smart column. Within 3-4 minutes the low water indicator lamp on the neptune heater came on. The energized low water indicator lamp confirmed the concha smart column float was working properly. Check valve test: the check valve discs for the conchasmart demonstrated that all three valves would move as the column valves were turned from one side to the other showing the discs themselves were free to move. A syringe was connected to the upper tube to push and pull upper check valves. Both upper valves moved back and forth freely with no impedance. The same syringe setup was used to confirm the proper operation of the lower check valve. Column/bottle test: the returned column was connected to a concha water bottle in correct position. Both upper and lower tubes were punctured into the concha water bottle. The conchasmart column filled to the bottom of level sensing tube and stopped as expected. The column was then connected to a 2410 comfort flo circuit with a 2411-04 neonate cannula. 3lpm of air flow was disconnected from the cannula with no water level increase into the circuit. The airflow was reconnected to the infant cannula at 3lpm. The nasal air was occluded allowing the pressure to build in the bottle until the comfort flo relief valve (also returned with the sample) actuated representing the worst case back pressure for the system. The airflow was disconnected again allowing the water bottle air pressure to escape through the column without pushing the column water level up to the circuit thus functioning appropriately. The complaint was unable to be confirmed as the circuit flooding was not able to be replicated even at the highest back pressure settings.
Patient Sequence No: 1, Text Type: N, H10
[158817834]
Customer reported a problem with the "comfort flow water getting in the circuit and getting to the patient" in the nicu. It was reported the bed and floor were wet. The patient experienced some desaturations and bradycardia and received bag mask ventilation to get the heart rate back up. The patient was changed to a vapotherm. Patient's condition after event was reported as "fine".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004365956-2019-00238 |
| MDR Report Key | 9075904 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-09-17 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-08-23 |
| Date Mfgr Received | 2019-08-23 |
| Date Added to Maude | 2019-09-17 |
| 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 | VICTORIA SANDLIN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| 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 | 2019-09-17 |
| Returned To Mfg | 2019-08-30 |
| Catalog Number | 2410 |
| Lot Number | 74C1900056 |
| Device Availability | R |
| 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 | 1. Required No Informationntervention | 2019-09-17 |