MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-23 for MAX AIR SYTEMS manufactured by Bio-medical Devices.
[52999625]
A battery pack malfunctioned resulting in smoke, sparking and flame in the recovery room of the hospital. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064338 |
| MDR Report Key | 5903928 |
| Date Received | 2016-08-23 |
| Date of Report | 2016-08-23 |
| Date of Event | 2016-08-23 |
| Date Added to Maude | 2016-08-25 |
| 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 | SERVICE AND TESTING PERSONNEL |
| 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 | MAX AIR SYTEMS |
| Generic Name | RECHARGEABLE LI-ION BATTERY & CELL |
| Product Code | MOY |
| Date Received | 2016-08-23 |
| Lot Number | 0901012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-MEDICAL DEVICES |
| Manufacturer Address | 17171 DAIMLER ST IRVINE CA 92614 US 92614 |
| Brand Name | MAX AIR SYSTEMS |
| Generic Name | PORT |
| Product Code | MOY |
| Date Received | 2016-08-23 |
| Catalog Number | 01531030 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BIO-MEDICAL DEVICES |
| Manufacturer Address | 17171 DAIMLES ST IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-23 |