MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CSM-1502; VITAL SIGNS MONITOR

Model Number	CSM-1502
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the monitor touch capabilities stopped working.According to the customer, they had to unplug it from the power source in order to reboot it.The customer pulled it from the room and replaced it with a functioning one.The customer will send in the unit to be exchanged.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 fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6: attempt #1: 05/24/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #2: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #3: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6: attempt #1: 05/24/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #2: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #3: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7: attempt #1: 05/24/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #2: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt #3: 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.D10: attempt #1: 05/24/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt #2: 06/01/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt #3: 06/05/2023 emailed the customer via microsoft outlook for device information: no reply was received.
Event or Problem Description
The customer reported that the monitor touch capabilities stopped working.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the monitor touch capabilities stopped working.According to the customer, they had to unplug it from the power source in order to reboot it.The customer pulled it from the room and replaced it with a functioning one.The customer will send in the unit to be exchanged.There was no patient injury reported.Investigation summary: nihon kohden (nk) received the device on 06/01/2023.The nk repair center (rc) evaluated the device on 06/14/2023 and 06/23/2023 and could not duplicate the complaint both times.The unit ran on a simulator for an extended period with no errors.A definitive root cause could not be determined since the complaint could not be duplicated.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 05/24/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B6 attempt # 1: 05/24/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.B7 attempt # 1: 05/24/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 06/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 06/05/2023 emailed the customer via microsoft outlook for patient information: no reply was received.D10 attempt # 1: 05/24/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 06/01/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 06/05/2023 emailed the customer via microsoft outlook for device information: no reply was received.Additional information: b4 date of this report d9 device available for evaluation? g3 date received by manufacturer g6 type of report h2 if follow up, what type? h3 device evaluated by manufacturer? h10 additional manufacturer narrative manufacturer references # (b)(4) follow up 001.
Event or Problem Description
The customer reported that the monitor touch capabilities stopped working.There was no patient injury reported.

• Brand Name: CSM-1502
• Common Device Name: VITAL SIGNS 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: 17088634
• Report Number: 8030229-2023-03592
• Device Sequence Number: 11464330
• Product Code: MHX
• UDI-Device Identifier: 04931921002056
• UDI-Public: 04931921002056
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: CSM-1502
• Device Catalogue Number: CSM-1502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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: NI.; NI.
• Patient Sex: Unknown