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.
[96175750]
(b)(4). It has been confirmed by vyaire that the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device. If a sample or any additional information becomes available a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[96175831]
Customer reported "the oxygen tubing disconnect from the bag and then it cannot be reconnected because the reservoir tubing is over the connection. Device was used on patient. Patient impact but no harm".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00397 |
| MDR Report Key | 7157822 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-02 |
| Date of Report | 2018-06-12 |
| Date of Event | 2017-12-05 |
| Date Mfgr Received | 2018-01-29 |
| 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 | RESPIRATORY THERAPIST |
| 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 | 0001128279 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2018-01-02 |