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 ORG-9110A manufactured by Nihon Kohden Corporation.
[181770243]
The customer reported that their multiple patient receiver (org) was displaying communication loss for 8 transmitters. Nk ts advised the customer to check the org closet and see if the org was powered off or had an error light blinking. The customer then reported that there was an error light that was blinking on the org. Nk ts instructed them to power off this org, but the issue persisted. The customer will be sending this unit in for a 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. Additional model information: 8 transmitters were used in conjunction with the org and are not the devices that experienced failure. Attempts to obtain the following information were made, but not provided: transmitters - model: n,i s/n: ni, approximate age of the device: no serial number was provided, so the age of the device is unknown. Device manufacturer date: ni, unique identifier (udi) #: ni.
Patient Sequence No: 1, Text Type: N, H10
[181770244]
The customer reported that their multiple patient receiver (org) was displaying communication loss for 8 transmitters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030229-2020-00139 |
| MDR Report Key | 9777605 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-02 |
| Date of Event | 2020-02-20 |
| Date Facility Aware | 2020-02-20 |
| Report Date | 2020-03-02 |
| Date Reported to FDA | 2020-03-02 |
| Date Reported to Mfgr | 2020-03-02 |
| Date Mfgr Received | 2020-02-20 |
| Device Manufacturer Date | 2013-04-18 |
| 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 | ORG-9110A |
| Generic Name | MULTIPLE PATIENT RECEIVER |
| Product Code | DRG |
| Date Received | 2020-03-02 |
| Model Number | ORG-9110A |
| Catalog Number | ORG-9110A |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 82 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 |