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

Model Number ORG-9110A

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 04/18/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the multiple patient receiver (org) kept dropping signals on all the transmitters.They replaced this org with a spare to continue patient monitoring.No patient harm was reported.The device was received by nk repair center and they reported that the issue could not be duplicated.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.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 b6 b7 attempt # 1: (b)(6) 2023 emailed the customer for patient's information and they responded that the patient's information were unknown.D10 concomitant medical device: the following devices were used in conjunction with the org: cns: (b)(4) model #: pu-621ra serial #: (b)(4).Device manufacturer data: 09/09/2011 unique identifier (udi) #: (b)(4).Returned to nihon kohden: dd/mm/yyyy zm transmitters: model #: zm-531pa serial #: (b)(4).Device manufacturer data: 15/01/2019 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na model #: zm-531pa serial #:(b)(4).Device manufacturer data: 27/05/2019 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na model #:zm-531pa serial #: (b)(4).Device manufacturer data: 01/02/2019 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na model #: zm-531pa serial #: (b)(4).Device manufacturer data: 22/07/2020 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na model #: zm-531pa serial #: (b)(4).Device manufacturer data: 09/03/2021 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na model #: zm-531pa serial #: (b)(4).Device manufacturer data: 23/12/2020 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na model #: zm-531pa serial #: (b)(4).Device manufacturer data: 24/04/2019 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na model #: zm-531pa serial #: (b)(4).Device manufacturer data: 31/10/2012 unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) kept dropping signals on all the transmitters.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the multiple patient receiver (org) kept dropping the signal to all monitored transmitters.No patient harm was reported.They replaced this org with a spare to continue patient monitoring.No patient harm was reported.Investigation summary: nihon kohden (nk) received the complaint device on 04/28/2023.Nk repair center (rc) evaluated the device on 05/02/2023 and duplicated the complaint.Nk rc found that the signal loss was due to internal noise on three of the org's zr-920p channel receivers.A definitive cause for why the channel receivers had noise could not be determined.However, possible causes may include physical damage or fluid intrusion from user mishandling.Power issues from the site outages or surges can affect circuitry of electronic components.Environmental issues such as electromagnetic radiation from other devices in the customer's site or wear-and-tear, which depends on the age of the device and frequency of use.A review of the complaint device's serial number shows that it is eleven (11) years old and has no other complaints.Due to the device's age, wear-and-tear may be a likely cause or contributing factor to the noise found on its channel receivers.The issue was resolved through component replacement.The nature of the complaint is likely related to the age of the device.Nk will continue to monitor and trend similar complaints.The following fields contain no information (ni), as an attempt to obtain information was made, but not provided: a2 - a6 b6 b7 attempt # 1: 05/01/2023 emailed the customer for patient's information and they responded that the patient's information was unknown.D10 concomitant medical device: the following devices were used in conjunction with the org: cns: cns-6201 model #: pu-621ra serial #: (b)(6) device manufacturer data: 09/09/2011 unique identifier (udi) #: (b)(4) returned to nihon kohden: dd/mm/yyyy zm transmitters: model #: zm-531pa serial #: (b)(6) device manufacturer data: 15/01/2019 unique identifier (udi) #: (b)(4) returned to nihon kohden: na model #: zm-531pa serial #: (b)(6) device manufacturer data: 27/05/2019 unique identifier (udi) #: (b)(4) returned to nihon kohden: na model #:zm-531pa serial #: (b)(6) device manufacturer data: 01/02/2019 unique identifier (udi) #: (b)(4) returned to nihon kohden: na model #: zm-531pa serial #: (b)(6) device manufacturer data: 22/07/2020 unique identifier (udi) #: (b)(4) returned to nihon kohden: na model #: zm-531pa serial #: (b)(6) device manufacturer data: 09/03/2021 unique identifier (udi) #: 04931921115107 returned to nihon kohden: na model #: zm-531pa serial #: (b)(6) device manufacturer data: 23/12/2020 unique identifier (udi) #: (b)(4) returned to nihon kohden: na model #: zm-531pa serial #: (b)(6) device manufacturer data: 24/04/2019 unique identifier (udi) #: (b)(4) returned to nihon kohden: na model #: zm-531pa serial #: (b)(6) device manufacturer data: 31/10/2012 unique identifier (udi) #: (b)(4) returned to nihon kohden: na additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the multiple patient receiver (org) kept dropping the signal to all monitored transmitters.No patient harm was reported.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16907891
• MDR Text Key: 314978393
• Report Number: 8030229-2023-03532
• 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
• Report Date: 08/15/2023

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-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 08/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2011
• 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: CNS.; CNS.; ZM TRANSMITTERS.; ZM TRANSMITTERS.