MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for VITAL SIGNS manufactured by Vyaire Medical, Inc..
[107461256]
Patient Sequence No: 1, Text Type: N, H10
[107461257]
Found an anesthesia circuit with manufacturing issue-co2 elbow has no opening to allow testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7490172 |
| MDR Report Key | 7490172 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-04-30 |
| Date of Event | 2018-04-23 |
| Report Date | 2018-04-24 |
| Date Reported to FDA | 2018-04-24 |
| Date Reported to Mfgr | 2018-04-24 |
| Date Added to Maude | 2018-05-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITAL SIGNS |
| Generic Name | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
| Product Code | DSA |
| Date Received | 2018-05-07 |
| Lot Number | 0001190545 |
| ID Number | A46X29XX |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other | 2018-05-07 |