| Report Number | 8030229-2019-00492 |
| MDR Report Key | 9121042 |
| Report Source | USER FACILITY |
| Date Received | 2019-09-25 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-08-31 |
| Date Facility Aware | 2019-09-03 |
| Report Date | 2019-09-25 |
| Date Reported to FDA | 2019-09-25 |
| Date Reported to Mfgr | 2019-09-25 |
| Date Mfgr Received | 2019-09-03 |
| Device Manufacturer Date | 2015-06-17 |
| Date Added to Maude | 2019-09-25 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHAMA MOOMAN |
| Manufacturer Street | SAFETY MGMT DEPT, QUALITY MGMT SEIBU BLDG 2, 4TH FLOOR 1-11-2 |
| Manufacturer City | KUSUNOKIDAI TOKOROZAWA, SAITAMA 359-8580 |
| Manufacturer Country | JA |
| Manufacturer Postal | 359-8580 |
| Manufacturer G1 | NIHON KOHDEN TOMIOKA CORPORATION |
| Manufacturer Street | 1-1 TAJINO ATTN: SHAMA MOOMAN |
| Manufacturer City | TOMIOKA CITY, 370-2314 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 370-2314 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |