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 2020-01-17 for ORG-9110A manufactured by Nihon Kohden Corporation.
[181768033]
The customer reported that their multiple patient receiver (org) went into intermittent signal loss with their telemetry devices. Nk ts directed the customer to the org closet to check the antenna lights. They reported that the a and b power supplies closest to the org had solid lights, and that the a and b power supplies closest to the antennas were blinking. The customer then checked the closet ceiling and found a loose connection on the both a and b side of the aacs. When they tightened the connection, all antennas lit up and no further signal loss issues were reported. No harm or injury reported. Nihon kohden continues to investigate the reported event. Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available. Details of the complaint: on (b)(6) 2019, customer at southeast health reported wmts intermittent signal loss on zm-521pa transmitter with serial# (b)(4). Service requested: assistance in troubleshooting. Service performed: nkts could duplicate the issue and assisted in troubleshooting. Nkts requested the biomed at customer to check the halls for antennas. A side signals were mostly dark, some were blinking. B side was all blinking. Nkts directed biomed to org closet and educated to check for lights. A, b power supplies closest to the org had solid lights and a, b power supplies closest to the antennas were blinking. Nkts requested biomed to check all connections in the closet for loose connections, which were reported to be tight. After cross verifying all connections, biomed found a loose connection on one of the a side aacs on the ceiling, which when tightened, connections on the a side came back up, however b side antennas 21,22,23, went out. He found a connection on the b side aac which was loose and once tightened all the antennas came back up. Nkts troubleshoot the connection on b side and identified loose connection on acc. The root cause of the intermittent signal loss was user error due to lose connection on ceiling of a side and b side acc. After tightening the connections, all a and b side antennas worked, and no further signal losses were observed. The issue was resolved. Investigation result: the root cause of the intermittent signal loss was user error due to lose connection on ceiling of a side and b side acc. After tightening the connections, all a and b side antennas worked, and no further signal losses were observed. Review of device history found no previously reported loose connection issues with the unit. The warranty of the device is under warranty till 12/29/2023. This is not a trending issue as according to customer's account. Investigation conclusion: the root cause of the intermittent signal loss was user error due to lose connection on ceiling of a side and b side acc. After tightening the connections, all a and b side antennas worked, and no further signal losses were observed. Review of device history found no previously reported loose connection issues with the unit. The warranty of the device is under warranty till 12/29/2023. This is not a trending issue as according to customer's account. Additional model information: the following transmitter was used in conjunction with the org, but was not the device that experience failure: transmitter - model: zm-521pa, s/n: (b)(4), approximate age of the device: 17 months, device manufacturer date: 07/24/2018, unique identifier (udi) #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181768034]
The customer reported that their multiple patient receiver (org) went into intermittent signal loss with their telemetry devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030229-2020-00031 |
| MDR Report Key | 9604434 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-26 |
| Date Facility Aware | 2020-01-13 |
| Report Date | 2020-01-17 |
| Date Reported to FDA | 2020-01-17 |
| Date Reported to Mfgr | 2020-01-17 |
| Date Mfgr Received | 2020-01-13 |
| Device Manufacturer Date | 2018-05-08 |
| Date Added to Maude | 2020-01-17 |
| 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 | 2020-01-17 |
| Model Number | ORG-9110A |
| Catalog Number | ORG-9110A |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 20 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 | 2020-01-17 |