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

Model Number	ORG-9100A
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported receiving an exchange tele from ticket (b)(4) and they're still unable to see the heart rate (hr).The unit is on a simulator and still not displaying the hr.Technical support (ts) asked the customer to release channel 9382 and test it on another unit's sector for channel 9126.When the customer did this, the unit displayed the hr.The issue appears to be with the receiver card on the org.There are 5 devices being used and 3 are not.The customer will try to find the org and call back with more information.It is unknown whether the unit was in patient use at the time.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.Udi related data quality updates corrected information: d4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.
Event or Problem Description
The customer reported receiving an exchange tele and they're still unable to see the heart rate (hr).The issue appears to be with the receiver card on the org.There was no patient injury reported.
Event or Problem Description
The customer reported receiving an exchange tele and they're still unable to see the heart rate (hr).The issue appears to be with the receiver card on the org.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported receiving an exchange tele from ticket (b)(4) and they're still unable to see the heart rate (hr).The unit is on a simulator and still not displaying the hr.Technical support (ts) asked the customer to release channel 9382 and test it on another unit's sector for channel 9126.When the customer did this, the unit displayed the hr.The issue appears to be with the receiver card on the org.There are 5 devices being used and 3 are not.The customer will try to find the org and call back with more information.It is unknown whether the unit was in patient use at the time.Investigation summary as the device with the reported issue was not returned for evaluation, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h11 additional manufacturer narrative.

• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 20903649
• Report Number: 8030229-2024-04542
• Device Sequence Number: 5004806
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: (01)04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2015
• 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
• Patient Sex: Unknown