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

Model Number	ORG-9100A
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer later found out that the uninterruptible power supply (ups) in the org closet was off.Once the ups was power back up, the org came back up.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.
Event or Problem Description
The customer reported that the org showed signal loss after a power "flicker" at the hospital.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the org showed signal loss after a power "flicker" at the hospital.The customer later found out that the uninterruptible power supply (ups) in the org closet was off.Once the ups was power back up, the org came back up.There was no patient injury reported.Investigation summary: the customer reported that the issue occurred after a power interruption at the facility.The customer found that the uninterruptable power supply (ups) had been turned off after the power loss event.After turning the ups back on, the signal loss cleared.As such, the root cause of signal loss is power loss due to third-party device.The risk for patient harm is mitigated in the design of the central monitoring stations as they are designed to notify clinicians in the case that signal occurs with org devices.As signal loss is easily noticeable to clinicians, alternate patient monitoring arrangements can be made in response to signal loss events.There is no evidence of an nk device malfunction.A capa is not warranted.Attempt # 1: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2022 emailed the customer via microsoft outlook for patient information: no reply was received.Manufacturer references # (b)(4).
Event or Problem Description
The customer reported that the org showed signal loss after a power "flicker" at the hospital.There was no patient injury reported.

• 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: 13442861
• Report Number: 8030229-2022-02430
• Device Sequence Number: 2110737
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/30/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2012
• 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: NI.; NI.
• Patient Sex: Unknown