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 2017-11-08 for CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT AH280 manufactured by Vyaire Medical, Inc.
[91411264]
Vyaire has received the complaint device for evaluation. The device has been processed through vyaire's decontamination process and has been shipped out to the manufacturing facility for further analysis. Once the investigation has been completed a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[91411265]
Customer reported vent circuit experiencing excessive rain out. There is no a/c blowing directly on the patient. No fan. The rain out is on the expiratory side. The patient has been on the vent 6 days. Temp probes were fully inserted and upright. "the patient did became tachypneic and appeared to be failing her wean. However, upon further inspection i found once the rainout was removed from the tube patient tachypneic resolved".
Patient Sequence No: 1, Text Type: D, B5
[109276231]
Unfortunately it has been confirmed that the sample was lost in transit from the decontamination facility. Additional information: unfortunately the representative samples were not available for further evaluation so the failure and root cause could not be confirmed. It has been identified that a defective crimping in the heater wire can potentially cause a bad electrical connection of heating wire to the power supply and therefore generate rain out in the circuit. Due to this potential failure a capa has been initiated with the following containment actions have been performed. Vyaire is doing inspection for 200% for wire resistance to ensure circuits are functional. Inspection for correct wire retainer position is also being performed. The following preventive actions are being implemented vyaire is qualifying crimp quality monitors on the crimper machines, and personnel are being retrained on the assembly procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00377 |
| MDR Report Key | 7011686 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-08 |
| Date of Report | 2018-02-21 |
| Date of Event | 2017-10-09 |
| Date Mfgr Received | 2018-02-01 |
| Date Added to Maude | 2017-11-08 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO. 85 PARQUE INDUSTRIAL MEX |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRCUIT, ADULT DUAL-LIMB, DUAL-HEAT |
| Generic Name | OXYGEN ADMINISTRATION KIT |
| Product Code | OGL |
| Date Received | 2017-11-08 |
| Returned To Mfg | 2017-09-13 |
| Catalog Number | AH280 |
| Lot Number | 0001129069 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | CERRADA VIA DE LA PRODUCCION NO. 85 PARQUE INDUSTRIAL MEX MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-08 |