MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G5 BEDSIDE MONITORING SYSTEM

Model Number	CU-152R
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	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported this unit had a missed alarm and they would like to send in the log files for review.According to the customer, the missed alarm happened around 7:30 to 9:30pm but she is not sure exactly what time.She is going to find out the timestamp and which alarm was missed (ie: (b)(6).There was no patient 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: (b)(6) 2024 a phone call was made in an attempt to gather device information; a voice mail was left for nikki to call me back with this information.Attempt # 2: (b)(6) 2024 a phone call was made in an attempt to gather device information; a voice mail was left for nikki to call me back with this information.Attempt # 3: (b)(6) 2024 a phone call was made in an attempt to gather device information; a voice mail was left for nikki to call me back with this information.
Event or Problem Description
The customer reported this unit had a missed alarm and they would like to send in the log files for review.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported this unit had a missed alarm and they would like to send in the log files for review.According to the customer, the missed alarm happened around 7:30 to 9:30pm but she is not sure exactly what time.She is going to find out the timestamp and which alarm was missed (ie: brady, tachy, asystole etc.).There was no patient injury reported.Investigation summary: a review of the logs provided by the customer showed that all alarms had been turned off "all alarms off" which caused alarms to be suppressed.The reported issue was due to user error (due to incorrect alarm settings).Nihon kohden's technical support (nk ts) tech provided the customer with education on resolving the issue and no further issues have been reported since.The following fields are not available (n/a) to this report: h4 device manufacturer date additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow up, what type? h11 additional manufacturer narrative.
Event or Problem Description
The customer reported this unit had a missed alarm and they would like to send in the log files for review.There was no patient injury reported.

• Brand Name: NIHON KOHDEN LIFE SCOPE G5 BEDSIDE MONITORING SYSTEM
• 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: 21020016
• Report Number: 8030229-2024-04597
• Device Sequence Number: 15736541
• Product Code: MHX
• UDI-Device Identifier: 04931921002056
• UDI-Public: (01)04931921002056
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K203435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: CU-152R
• Device Catalogue Number: CU-152R
• 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: 12/03/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown