MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-23 for BAG EASY RESUSCITATOR manufactured by Westmed Inc..
[109037964]
The pt was being resuscitated. During defibrillation, the defib pads arched creating a spark. The spark ignited the resuscitation (ambu) bag and caused a fire. The staff quickly removed the product from the pt to the floor and put out the fire. This created burns to the pt's right chest/arm and face. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077413 |
| MDR Report Key | 7537292 |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-21 |
| Date of Event | 2018-05-08 |
| Date Added to Maude | 2018-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAG EASY RESUSCITATOR |
| Generic Name | BAG EASY RESUSCITATOR |
| Product Code | BTM |
| Date Received | 2018-05-23 |
| Lot Number | 033018U15 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTMED INC. |
| Brand Name | ONESTEP CPR COMPLETE |
| Generic Name | ONESTEP CPR COMPLETE |
| Product Code | LIX |
| Date Received | 2018-05-23 |
| Lot Number | 1718C |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-23 |