MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION; MULTIPLE PATIENT RECEIVER

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)

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

Event Date 07/22/2022

Event Type  malfunction  

Event Description

The biomedical engineer reported that the telemetry transmitter missed a vtach alarm for a patient.The occurrence date happened a week before or longer from the reported date.The data from the telemetry transmitter is transmitted from the multiple patient receiver (org) to be displayed on the central nurse's station (cns).No patient harm reported.

Manufacturer Narrative

The biomedical engineer reported that the telemetry transmitter missed a vtach alarm for a patient.The occurrence date happened a week before or longer from the reported date.The data from the telemetry transmitter is transmitted from the multiple patient receiver (org) to be displayed on the central nurse's station (cns).No patient harm reported.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(s) were being used in conjunction with the org, but model and serial number information was noted as no information (ni), as attempts to obtain information were made but information was not provided.Central nurse's station.Model: ni.Sn: ni.Telemetry transmitter.Model: zm-530pa.Sn: (b)(4).Device manufacturer date: 11/25/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the telemetry transmitter missed a vtach alarm at the central nurse's station (cns).No patient harm was reported.Investigation summary: alarms are triggered by limits configured in the device's alarm settings.Devices are configured as per customer requirements by the nk clinical staff at the time the devices are taken live.Additional changes to device settings can be made post "go-live" by the customer based on the facility's policies, protocols, and processes.The root cause cannot be determined.The customer did not provide device logs after 5 days of the request.Logs relating to the event can no longer be obtained.A complaint history review of the reported device revealed no subsequent complaints relating to missed alarms.It is likely that the customer changed alarm settings to resolve the issue.It is also possible that the alarm was silenced or ignored.As the customer did not provide the needed information to confirm the issue and there has not been a recurrence, further action is not warranted.Telemetry transmitter : model: zm-530pa.Sn: (b)(6).Device manufacturer date: 11/25/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: not returned.

Event Description

The biomedical engineer (bme) reported that the telemetry transmitter missed a vtach alarm at the central nurse's station (cns).No patient harm reported.

• Brand Name: NI
• 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: 15307632
• MDR Text Key: 305358356
• Report Number: 8030229-2022-03043
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CENTRAL NURSE'S STATION; CENTRAL NURSE'S STATION; TRANSMITTER; ZM-530PA SN (B)(6)