MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

According to the customer, they all went into signal loss at the same time.When they investigated, they couldn't find any issue and the issue itself never came up again.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.Concomitant medical device: the following device was used in conjunction with the org: zm transmitters: model #: 521, serial #s: (b)(4), device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.

Event Description

The customer reported that the org showed 4 transmitters in signal loss.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that four (4) transmitters were in signal loss with the multiple patient receiver (org), all going into signal loss at the same time.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.By the time the customer had gotten in contact with nka tech support, the issue of signal loss had seemingly resolved itself and did not recur.As the signal loss was resolved without intervention by nka, it is likely that the cause of signal loss was related to environmental factors.Interference from external sources such as construction can interfere with wmts signals and would result in temporary signal loss.A serial number review of the reported device does not reveal additional related complaints.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the org: zm transmitters: model #: zm-531pa serial (b)(6) device manufacturer data: 10/23/2015 , (b)(4) returned to nihon kohden: na d10 concomitant medical device: the following devices were used in conjunction with the org: zm transmitters: model #: zm-521pa serial (b)(6) device manufacturer data: 06/25/2018 , (b)(4) returned to nihon kohden: na zm transmitters: model #: zm-521pa serial (b)(6) device manufacturer data: 08/27/2019 , (b)(4) returned to nihon kohden: na additional information: b4 date of this report g6 type of report h2 if follow-up, what type? h10 additional manufacturer narrative corrected information: b4 date of this report: corrected the date to reflect the correct submission date of 09/27/2023.

Event Description

The customer reported that four (4) transmitters were in signal loss with the multiple patient receiver (org).There was no patient injury reported.

Event Description

The customer reported that four (4) transmitters were in signal loss with the multiple patient receiver (org).There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that four (4) transmitters were in signal loss with the multiple patient receiver (org), all going into signal loss at the same time.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.By the time the customer had gotten in contact with nka tech support, the issue of signal loss had seemingly resolved itself and did not recur.As the signal loss was resolved without intervention by nka, it is likely that the cause of signal loss was related to environmental factors.Interference from external sources such as construction can interfere with wmts signals and would result in temporary signal loss.A serial number review of the reported device does not reveal additional related complaints.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 - b7 attempt # 1: 11/29/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 11/30/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 12/01/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the org: zm transmitters: model #: zm-531pa.Serial #: (b)(6).Device manufacturer data: 10/23/2015.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: nad10 concomitant medical device: the following devices were used in conjunction with the org: zm transmitters: model #: zm-521pa.Serial #s: (b)(6).Device manufacturer data: 06/25/2018.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na zm transmitters: model #: zm-521pa serial #s: (b)(6).Device manufacturer data: 07/03/2018.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Zm transmitters: model #: zm-521pa serial #s: (b)(6).Device manufacturer data: 08/27/2019.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

• Brand Name: ORG-9110A
• 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12925695
• MDR Text Key: 283509959
• Report Number: 8030229-2021-02056
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2017
• 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: 4 ZM TRANSMITTERS.; 4 ZM TRANSMITTERS.; ZM TRANSMITTERS.