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 2020-03-02 for GF-210RA manufactured by Nihon Kohden Corporation.
[181769894]
The customer also reported that their multi-gas unit was displaying an intermittent flat line for co2 waves during a procedure. The biomedical engineer (bme) tested the unit in his shop for a couple of hours, breathing into the tube every half hour in hopes of re-producing this issue, but the unit worked exactly as expected. No harm or injury was reported during the initial matter. The customer will be sending this multi-gas unit in for an evaluation. 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
[181769895]
The customer also reported that their multi-gas unit was displaying an intermittent flat line for co2 waves during a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030229-2020-00136 |
| MDR Report Key | 9777604 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-18 |
| Date Facility Aware | 2020-02-18 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Reported to Mfgr | 2020-03-02 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2017-02-14 |
| Date Added to Maude | 2020-03-02 |
| 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 | GF-210RA |
| Generic Name | MULTI-GAS UNIT |
| Product Code | CCK |
| Date Received | 2020-03-02 |
| Model Number | GF-210RA |
| Catalog Number | GF-210RA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 36 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 | 2020-03-02 |