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 2018-08-08 for INFANT HEATED WIRE CIRCUIT AH265 manufactured by Vyaire Medical.
[116428533]
At this time, vyaire medical 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
[116428534]
The respiratory therapist reported: rain-out is a big problem on intubated baby. Draining circuit very frequently. Rain -out is setting off high respiration rate alarm. Connection at the swivel falls out easily.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00008 |
| MDR Report Key | 7762988 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2018-08-08 |
| Date of Report | 2018-08-15 |
| Date of Event | 2018-06-23 |
| Date Mfgr Received | 2018-08-15 |
| Date Added to Maude | 2018-08-08 |
| 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 |
| 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 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | PRODUCTOS UR |
| 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 | 2018-08-08 |
| Catalog Number | AH265 |
| Lot Number | 0001119873 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-08-08 |