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 2018-08-15 for AIRLIFE RESUSCITATION, ADULT, WITH MASK, 40 OXYGEN RESERVOIR TUBING, PEEP VALVE 2K8036 manufactured by Vyaire Medical.
[117206077]
The reported issue has been identified to be related to a known issue being addressed through a field corrective action. Remediation and repair of the suspect device has been completed and no further investigation is required.
Patient Sequence No: 1, Text Type: N, H10
[117206078]
The customer reported during mock codes, there have been multiple instance where the white cap that covers the monitoring side port on the mechanical resuscitator (ambu-bag) opens. The customer reported this results in effective bagging as ventilator goes through the port rather than to the patient. At this time, it is unknown whether or not there was any patient consequence associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2018-00012 |
| MDR Report Key | 7786109 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-15 |
| Date of Report | 2018-08-24 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-08-24 |
| Date Added to Maude | 2018-08-15 |
| 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 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | PRODUCTOS UR |
| Manufacturer Street | CERRADAV PARQUE UNDUSTRIAL MEXICALI II |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1571-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIRLIFE RESUSCITATION, ADULT, WITH MASK, 40 OXYGEN RESERVOIR TUBING, PEEP VALVE |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2018-08-15 |
| Catalog Number | 2K8036 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Other | 2018-08-15 |