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 2020-03-02 for AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, PEDIATRIC MASK, PR 2K8020 manufactured by Carefusion 2200, Inc..
[188824173]
Only the photo has been evaluated. No sample returned. The customer stated it is a device malfunction, where the device did not do what it was supposed to do. Vyaire file identification: any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[188824174]
The customer reported that the airlife pediatric manual resuscitator experienced a pediatric bag failure during patient use. The customer confirmed that the problem was quickly identified and there was no patient harm associated with this reported event. As an intervention, they got another pediatric bag and it worked just fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00076 |
| MDR Report Key | 9777329 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESERVOIR BAG, PEDIATRIC MASK, PR |
| Generic Name | ANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) |
| Product Code | OFP |
| Date Received | 2020-03-02 |
| Model Number | AIRLIFE PEDIATRIC MANUAL RESUSCITATOR, OXYGEN RESE |
| Catalog Number | 2K8020 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC. |
| Manufacturer Address | 75 N FAIRWAY DR VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-02 |