MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-02 for AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M 2K8004 manufactured by Vyaire Medical.
[188824107]
As of this time, no sample has been returned. There are three(3) lot numbers available for this sample: 0004118094, 0004111662 and 0004095580. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[188824108]
The customer reported that the airlife adult manual resuscitator experienced a defect problem. In post anesthesia care unit, patient experienced difficulty breathing. So they bagged the patient to continue breathing. But due to hose at base of ambu bag was kinked or pinched, it did not allow adequate oxygen to flow into the ambu bag. When the issue occurred, the patient's spo2 were not coming up from low 80%, once identified staff were able to get line open enough to bring patient's spo2 up to 99%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00079 |
| MDR Report Key | 9777287 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-03-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
| Manufacturer Street | CERRADA V 85 PARQUE UNDUSTRIAL MEX III |
| 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 | AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M |
| Generic Name | CARDIOPULMONARY RESUSCITATION AID KIT |
| Product Code | OEV |
| Date Received | 2020-03-02 |
| Model Number | AIRLIFE ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXY |
| Catalog Number | 2K8004 |
| Lot Number | 0004118094, 0004111662 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-02 |