MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE TR; BEDSIDE MONITOR

Model Number	MU-651RA
Medical Device Problem Codes	No Audible Alarm (1019); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Biomedical engineer (bme) reported that the bedside monitor (bsm) in one of the rooms is not showing any arrythmia recall when the patient has had arrhythmia's.When the bme tried to trigger an alarm by adjusting the heart rate (hr) to a low limit, it did not trigger an alarm, when bme set hr to a high limit there was still no alarm from the device.There was no patient harm or injury 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.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 03/06/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 03/17/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 03/26/2025 emailed the customer via microsoft outlook for all information in the ni list above: the customer replied that the issue was resolved but did not specify how it was resolved and did not provide any of the requested information.
Event or Problem Description
Biomedical engineer (bme) reported that the bedside monitor (bsm) in one of the rooms is not showing any arrythmia recall when the patient has had arrhythmia's.When the bme tried to trigger an alarm by adjusting the heart rate (hr) to a low limit, it did not trigger an alarm, when bme set hr to a high limit there was still no alarm from the device.There was no patient harm or injury reported.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) was not showing any arrythmia recall when the patient had arrhythmia's.When the bme tried to trigger an alarm by adjusting the heart rate (hr) alarm limits to a lower or higher limit, the device did not trigger an alarm.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) was not showing any arrythmia recall when the patient had arrhythmia's.When the bme tried to trigger an alarm by adjusting the heart rate (hr) alarm limits to a lower or higher limit, the device did not trigger an alarm.There was no patient harm or injury reported.Investigation summary: the customer later reported that they had resolved the issue, but did not give any details on how it was resolved.The customer was unresponsive after multiple follow-up requests for specific resolution details.The device was not returned for evaluation.The complaint could not be confirmed.As such a root cause could not be determined.Nk will continue to trend and monitor the reported issue.Additional information: b4 date of this report.D10 concomitant medical device.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H11 additional manufacturer narrative.

• Brand Name: LIFE SCOPE TR
• Common Device Name: BEDSIDE MONITOR
• 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: 21732963
• Report Number: 8030229-2025-04855
• Device Sequence Number: 21016560
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: (01)04931921103548
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• 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): 06/05/2025

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: MU-651RA
• Device Catalogue Number: MU-651RA
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2020
• 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: CNS
• Patient Sex: Unknown