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 2018-01-02 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Vyaire Medical, Inc.
[96187161]
(b)(4). -vyaire has reached out to customer to provide the complaint device for further investigation. At this time we are currently waiting for the sample. If the customer provides the sample for further investigation or additional information is obtained, vyiare will provided a follow up emdr.
Patient Sequence No: 1, Text Type: N, H10
[96187162]
Customer reported "the diaphragm at the gas inlet of the bag was not in place and we were unable to ventilate with the bag". The clinician became aware of the issue due to the spo2 not increasing. Customer reported that there was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00399 |
| MDR Report Key | 7158545 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-02 |
| Date of Report | 2018-03-28 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-02-22 |
| Date Added to Maude | 2018-01-02 |
| 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 G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO. 85, PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESUS, ADLT W/MASK, 40" TBG, 6/CS |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2018-01-02 |
| Catalog Number | 2K8005 |
| Lot Number | 0001121459 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-01-02 |