MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-08-03 for INFANT HEATED WIRE CIRCUIT AH265 manufactured by Vyaire Medical.
[115972176]
At this time, vyaire has not received the sample for investigation. If additional information is received, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[115972177]
The nurse reported excessive water condensation while using the infant heated wire circuit. The nurse observed excessive condensation in both the expiratory and inspiratory limbs and the baby's face is constantly wet requiring multiple re-tapes. The nurse reported the circuit was changed out and no patient consequence associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00004 |
| MDR Report Key | 7748452 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-03 |
| Date of Report | 2018-08-22 |
| Date of Event | 2018-06-25 |
| Date Mfgr Received | 2018-08-22 |
| Date Added to Maude | 2018-08-03 |
| 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 Phone | 8727570116 |
| Manufacturer G1 | PRODUCTOS UR |
| Manufacturer Street | HILARIO RUELAS 3506 EL C |
| 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 | INFANT HEATED WIRE CIRCUIT |
| Generic Name | OXYGEN ADMINISTRATION KIT |
| Product Code | OGL |
| Date Received | 2018-08-03 |
| Catalog Number | AH265 |
| 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 |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-03 |