| Report Number | 8030229-2020-00069 |
| MDR Report Key | 9690760 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-01-23 |
| Date Facility Aware | 2020-01-23 |
| Report Date | 2020-02-10 |
| Date Reported to FDA | 2020-02-10 |
| Date Reported to Mfgr | 2020-02-10 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2014-01-28 |
| Date Added to Maude | 2020-02-10 |
| 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 CORPORATION |
| Manufacturer Street | 1-31-4 NISHIOCHIA, SHINJUKU-KU ATTN: SHAMA MOOMAN |
| Manufacturer City | TOKYO, 161-8560 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 161-8560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |