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 2017-07-12 for RESUS, ADLT W/MASK, 40" TBG, 6/CS 2K8005 manufactured by Vyaire Medical, Inc.
[79889205]
Vyaire has received the complaint device and is currently performing an investigation into the reported issue. A follow up mdr will be sent once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[79889206]
The customer reported that the "mask won't release from the elbow. Bag was used on a trach patient. There was no patient harm".
Patient Sequence No: 1, Text Type: D, B5
[109540726]
Device evaluation: one opened sample was received for further evaluation. During visual inspection, it was observed that the sample exhibited the textured surface finish on the connectors outer diameter. The unit was submitted to a pull test and the reported failure mode code not be confirmed the pull test results were within specification. Based on this investigation, the reported failure was not confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00354 |
| MDR Report Key | 6708490 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-12 |
| Date of Report | 2017-10-12 |
| Date of Event | 2017-06-14 |
| Date Mfgr Received | 2017-08-09 |
| Date Added to Maude | 2017-07-12 |
| 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 V PARQUE INDUSTRIAL MEX |
| 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 | 2017-07-12 |
| Returned To Mfg | 2017-07-10 |
| Catalog Number | 2K8005 |
| Lot Number | 0001046154 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | CERRADA V?A DE LA PRODUCCI?N NO.85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-12 |