MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-01-03 for AG-920RA manufactured by Nihon Kohden Corporation.
[188835939]
The customer reported that their multi-gas unit was displaying "cal error" alarms. The device also displayed "gas unspecified accuracy," and the customer reported the co2 reading to be about half of what it should have been. The customer tried changing the water trap and dry line, but the issue remained. He replaced the unit with another backup on hand. The customer received a loaner device and is sending in the defective device for repair. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[188835940]
The customer reported that their multi-gas unit was displaying "cal error" alarms. The device also displayed "gas unspecified accuracy," and the customer reported the co2 reading to be about half of what it should have been.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030229-2020-00002 |
| MDR Report Key | 9547100 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-09 |
| Date Facility Aware | 2019-12-09 |
| Report Date | 2020-01-03 |
| Date Reported to FDA | 2020-01-03 |
| Date Reported to Mfgr | 2020-01-03 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2012-07-19 |
| Date Added to Maude | 2020-01-03 |
| 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 |
| Brand Name | AG-920RA |
| Generic Name | MULTI-GAS UNIT |
| Product Code | CCK |
| Date Received | 2020-01-03 |
| Model Number | AG-920RA |
| Catalog Number | AG-920RA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 88 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIHON KOHDEN CORPORATION |
| Manufacturer Address | 1-31-4 NISHIOCHIA, SHINJUKU-KU ATTN: SHAMA MOOMAN TOKYO, 161-8560 JA 161-8560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |