MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-01 for BREATHTECH HYPERINFLATION SYSTEM HS34151 HS 34000 manufactured by Sunmed Holdings, Llc.
| Report Number | 8850418 |
| MDR Report Key | 8850418 |
| Date Received | 2019-08-01 |
| Date of Report | 2019-07-16 |
| Date of Event | 2019-07-14 |
| Report Date | 2019-07-16 |
| Date Reported to FDA | 2019-07-16 |
| Date Reported to Mfgr | 2019-08-01 |
| Date Added to Maude | 2019-08-01 |
| 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 |
| Brand Name | BREATHTECH HYPERINFLATION SYSTEM |
| Generic Name | RESUSCITATOR, MANUAL, NON SELF-INFLATING |
| Product Code | NHK |
| Date Received | 2019-08-01 |
| Model Number | HS34151 |
| Catalog Number | HS 34000 |
| Lot Number | 303160 |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNMED HOLDINGS, LLC |
| Manufacturer Address | 2710 NORTHRIDGE DR NW STE A GRAND RAPIDS MI 49544 US 49544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-01 |