MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-11 for 2000-6 manufactured by Max Air Systems.
[123429195]
While charging, a papr battery had burnt out causing lot of smoke. Code red was alerted. These batteries are used in the papr helmets. Max air systems, order no. (b)(4), part number: 01531032, capacity: 2. 0 ah volts 14. 8v.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7956102 |
| MDR Report Key | 7956102 |
| Date Received | 2018-10-11 |
| Date of Report | 2018-08-27 |
| Date of Event | 2018-08-21 |
| Report Date | 2018-09-04 |
| Date Reported to FDA | 2018-09-04 |
| Date Reported to Mfgr | 2018-10-11 |
| Date Added to Maude | 2018-10-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | RESPIRATOR, SURGICAL |
| Product Code | MSH |
| Date Received | 2018-10-11 |
| Catalog Number | 2000-6 |
| Lot Number | 0906022 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAX AIR SYSTEMS |
| Manufacturer Address | 17171 DAIMLER ST IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-11 |