MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9100A; MULTIPLE PATIENT RECEIVER

Model Number	ORG-9100A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bsm) reported that they were experiencing signal loss or intermittent signal loss and would appreciate it if you could assist with information for the issue.Tech support (ts) suggested that it could be an issue with the multiple patient receiver (org) or something along the antenna system, but the customer did not troubleshoot as they stated that they looked at all that already.They have been experiencing issue since (b)(6) 2021 and would like to get someone out to the site to resolve their issue.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bsm) reported that they were experiencing signal loss or intermittent signal loss and would appreciate it if you could assist with information for the issue.Tech support (ts) suggested that it could be an issue with the multiple patient receiver (org) or something along the antenna system, but the customer did not troubleshoot as they stated that they looked at all that already.They have been experiencing issue since (b)(6) 2021 and would like to get someone out to the site to resolve their issue.No patient harm was reported.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 device information: concomitant medical device: the following device(s) were being used in conjunction with the org.Central nurse's stations model: cns-6801a.Sn: (b)(4).Model: cns-6801a.Sn: (b)(4).Model: cns-6801a.Sn: (b)(4).Multiple patient receivers model: org-9100a.Sn: (b)(4).Model: org-9110a.Sn: (b)(4).Model: org-9110a.Sn: (b)(4).Model: org-9110a.Sn: (b)(4).Telemetry transmitters model: zm-531pa.Sn: (b)(4).Model: zm-540pa.Sn: (b)(4).Model: zm-541pa.Sn: (b)(4).Model: zm-541pa.Sn: (b)(4).
Event or Problem Description
The biomedical engineer (bsm) reported that they were experiencing signal loss or intermittent signal loss and would appreciate it if you could assist with information for the issue.Tech support (ts) suggested that it could be an issue with the multiple patient receiver (org) or something along the antenna system, but the customer did not troubleshoot as they stated that they looked at all that already.They have been experiencing issue since 12/2021 and would like to get someone out to the site to resolve their issue.No patient harm was reported.
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bsm) reported that they were experiencing signal loss or intermittent signal loss and would appreciate it if you could assist with information for the issue.Tech support (ts) suggested that it could be an issue with the multiple patient receiver (org) or something along the antenna system, but the customer did not troubleshoot as they stated that they looked at all that already.They have been experiencing issue since 12/2021 and would like to get someone out to the site to resolve their issue.No patient harm was reported.Service requested / performed: based on the evaluation performed by nk repair center, the issue of signal loss was duplicated, and the ecg board was recommended for replacement.Physical damage was observed.Investigation conclusion: based on the age of the device and the observation of physical damage to the device, the root cause for the signal loss is most likely related to wear and tear or physical damage to the transmitter internal components.It is unlikely that the issue occurred as a result of a deficiency in design or manufacturing.

• Brand Name: ORG-9100A
• Common Device Name: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13880388
• Report Number: 8030229-2022-02644
• Device Sequence Number: 20149633
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K071058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ORG-9100A
• Device Catalogue Number: ORG-9100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 03/24/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CNS-6801A SN (B)(6); CNS-6801A SN (B)(6); CNS-6801A SN (B)(6); CNS-6801A SN (B)(6); CNS-6801A SN (B)(6); CNS-6801A SN (B)(6); ORG-9100A SN (B)(6); ORG-9100A SN (B)(6); ORG-9110A SN (B)(6); ORG-9110A SN (B)(6); ORG-9110A SN (B)(6); ORG-9110A SN (B)(6); ORG-9110A SN (B)(6); ORG-9110A SN (B)(6); ZM-531PA SN (B)(6); ZM-531PA SN (B)(6); ZM-540PA SN (B)(6); ZM-540PA SN (B)(6); ZM-541PA SN (B)(6); ZM-541PA SN (B)(6); ZM-541PA SN (B)(6); ZM-541PA SN (B)(6)
• Patient Sex: Unknown