MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-05 for LONG PAT CKT,F&P850, BOX 4, 31A 773997 manufactured by Vyaire Medical..
[188823754]
At this time, vyaire has not received the suspect device for evaluation. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[188823755]
The customer reported a defective 3100a circuit, the customer explained that when they connect the circuit on the unit, the heater alarmed, they tried a new temp ports and humidifier but the device still alarming. The customer replaced the circuit and solved the issue. The problem happened while connected on a patient, however, the customer also confirmed that there was no harm or injury that was associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00072 |
| MDR Report Key | 9673498 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-08 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-02-05 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | PRODUCTOS UR |
| Manufacturer Street | CERRADA V #85, PARQUE UNDUSTRIAL MEX III |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LONG PAT CKT,F&P850, BOX 4, 31A |
| Generic Name | VENTILATOR, HIGH FREQUENCY |
| Product Code | LSZ |
| Date Received | 2020-02-05 |
| Model Number | LONG PAT CKT,F&P850, BOX 4, 31A |
| Catalog Number | 773997 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-05 |