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

Model Number ORG-9100A

Device Problems Loss of Power (1475); Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2021

Event Type  malfunction  

Event 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.

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 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.

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
• Type of Device: 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
• MDR Text Key: 286129449
• Report Number: 8030229-2022-02409
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103883
• UDI-Public: 04931921103883
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 12/25/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MULTIPLE CNS(S); MULTIPLE CNS(S); MULTIPLE ORG(S); MULTIPLE ORG(S)