MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-07-26 for PED, 40" TUBE RESVR, PED MASK 2K8008 manufactured by Vyaire Medical.
[115195707]
(b)(4). At this time, vyaire has not received the suspect device/component for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[115195708]
Customer reported: child had neuro event where he/she forgot to breath. On 5 liter of o2 on tank and increased to 8 liters. Nurse was alerted to this issue when she noticed there was no airflow through bag. Nurse reported there was no patient harm or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00002 |
| MDR Report Key | 7724481 |
| Report Source | OTHER |
| Date Received | 2018-07-26 |
| Date of Report | 2018-08-14 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-08-14 |
| Date Added to Maude | 2018-07-26 |
| 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 MEXICALI, B.C., MEXICO |
| 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 | PED, 40" TUBE RESVR, PED MASK |
| Generic Name | PED, 40" TUBE RESVR, PED MASK, MANO, P/O VALVE, 10' O2 TBG |
| Product Code | OEV |
| Date Received | 2018-07-26 |
| Catalog Number | 2K8008 |
| 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 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-26 |