MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM; DATA ACQUISITION UNIT (FOR CU-171R, CU-172R)

Model Number	JA-170P
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that this g7 is constantly freezing.There was no patient injury reported.
Additional Manufacturer Narrative
The customer reported that this g7 is constantly freezing.According to the customer the issue happens twice a month and the only fix is to remove the battery and unplug the power cable.The customer stated that the issue is due to the dau.Technical support (ts) asked the customer to try changing out the dau and interface cable.The issue was discovered during setup.The unit was not in patient use at the time.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.D10 concomitant medical device: the following device was used in conjunction with the data acuisition unit (dau): g7 cu-172ra: model #: cu-172-ra.Serial (b)(6).Device manufacturer date: 04/15/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: no.
Additional Manufacturer Narrative
Details of complaint: the customer reported that this g7 is constantly freezing.According to the customer the issue happens twice a month and the only fix is to remove the battery and unplug the power cable.The customer stated that the issue is due to the dau.Technical support (ts) asked the customer to try changing out the dau and interface cable.The issue was discovered during setup.The unit was not in patient use at the time.Investigation summary: the repair center tested the returned unit for an extended 96 hours and they were unable to duplicate any freezing issues.The reported issue could not be duplicated or confirmed.A definitive root cause could not be determined.D10 concomitant medical device: the following device was used in conjunction with the data acuisition unit (dau): g7 cu-172ra: model #: cu-172-ra.Serial #: (b)(6).Device manufacturer date: 04/15/2022.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: no.
Event or Problem Description
The customer reported that this g7 is constantly freezing.There was no patient injury reported.

• Brand Name: NIHON KOHDEN LIFE SCOPE G7 BEDSIDE MONITORING SYSTEM
• Common Device Name: DATA ACQUISITION UNIT (FOR CU-171R, CU-172R)
• 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: 19952236
• Report Number: 8030229-2024-04403
• Device Sequence Number: 8839451
• Product Code: MHX
• UDI-Device Identifier: 04931921004593
• UDI-Public: (01)04931921004593
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213316
• 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): 10/28/2024

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: JA-170P
• Device Catalogue Number: JA-170P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: G7 CU-172RA; G7 CU-172RA
• Patient Sex: Unknown