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

Model Number	ORG-9100A
Medical Device Problem Codes	Loss of Power (1475); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the facility experienced a power surge and everything came back up except the multiple patient receiver (org's) while in use with patients.No patient harm was reported.Nihon kohden technician had the bme reboot the multiple patient receiver (org's) and when the bme did this the multiple patient receiver (org's) still had the link light off.The bme said that the switch that the multiple patient receiver (org's) are connected to is an (b)(4) switch.Nk technician recommended to the bme to contact the (b)(4) technical support since the issue with their switches.
Additional Manufacturer Narrative
The reported issue is due to a power surge causing the non nihon kohden power switch to be defective.Concomitant medical device: the following device(s) was used in conjunction with the org: cns(s): model #: pu-621ra, serial #: (b)(4), device manufacturer data: 02/26/2013, unique identifier (udi) #: (b)(4), model #: pu-621ra, serial #: (b)(4), device manufacturer data: 02/26/2013, unique identifier (udi) #: (b)(4), model #: pu-621ra, serial #: (b)(4), device manufacturer data: 02/28/2013, unique identifier (udi) #: (b)(4), model #: pu-621ra, serial #: (b)(4), device manufacturer data: 02/28/2013, unique identifier (udi) #: (b)(4), org: model #:mu-970ra, serial #: (b)(4), device manufacturer data: 11/21/2006, unique identifier (udi) #: (b)(4).
Event or Problem Description
The biomedical engineer (bme) reported that the facility experienced a power surge and everything came back up except the multiple patient receiver (org's) while in use with patients.No patient harm was reported.Nihon kohden technician had the bme reboot the multiple patient receiver (org's) and when the bme did this the mulitple patient receiver (org's) still had the link light off.The bme said that the switch that the multiple patient receiver (org's) are connected to is an allied telesys switch.Nk technician recommended to the bme to contact the allied telesys technical support since the issue with their switches.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the facility experienced a power surge and everything came back up except the multiple patient receiver (org's) while in use with patients.No patient harm was reported.Nihon kohden technician had the bme reboot the multiple patient receiver (org's) and when the bme did this the mulitple patient receiver (org's) still had the link light off.The bme said that the switch that the multiple patient receiver (org's) are connected to is an allied telesys switch.Nk technician recommended to the bme to contact the allied telesys technical support since the issue is with their switches.Investigation summary: the reported issue is due to a power surge causing the non nihon kohden power switch to be defective.No further issues of this type on this device have been received since this report.The issue was most likely resolved by replacing the network switch (non-nk device).As the issue of communication loss cannot be confirmed to be caused by the nk device and the issue was resolved by the replacement of the third party network switch, therefore a corrective action or preventative action (capa) is not warranted.Attempt # 3: 01/19/2022 called the customer and was informed that the person who reported the issue no longer works at the facility and they cannot provide any more information.Additional device information: d10 concomitant medical device: the following device(s) was used in conjunction with the org: cns(s): model #: pu-621ra, serial #: (b)(6), device manufacturer data: 02/26/2013, unique identifier (udi) #: (b)(4).Model #: pu-621ra, serial #: (b)(6), device manufacturer data: 02/26/2013 unique identifier (udi) #: (b)(4).Model #: pu-621ra, serial #: (b)(6), device manufacturer data: 02/28/2013, unique identifier (udi) #: (b)(4).Model #: pu-621ra, serial #: (b)(6), device manufacturer data: 02/28/2013, unique identifier (udi) #: (b)(4).Org: model #:mu-970ra, serial #: (b)(6), device manufacturer data: 11/21/2006, unique identifier (udi) #: (b)(4).Manufacturer narrative b4: date of this report g3: date received by manufacturer g6: type of report h2: if follow-up, what type? h6: adverse event - investigation findings, investigation conclusions h10: additional narrative/data.

• 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: 13311338
• Report Number: 8030229-2022-02409
• Device Sequence Number: 4933532
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2022

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: 12/25/2021
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 01/20/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• 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: MULTIPLE CNS(S); MULTIPLE CNS(S); MULTIPLE ORG(S); MULTIPLE ORG(S)
• Patient Sex: Unknown