MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CSM-1501; VITAL SIGNS MONITOR

Model Number	CSM-1501
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nk employee field support reported that the g5 monitoring unit was spontaneously rebooting.The unit was installed 2 months ago.Not in patient use.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 contains no information (ni), as attempts to obtain the information were made, but not provided: d10.Attempt # 1: (b)(6) 2024 emailed the nk employee if a concomitant medical device was used.No reply was received.Attempt # 2: (b)(6) 2024 emailed the nk employee if a concomitant medical device was used.No reply was received.Attempt # 3: (b)(6) 2024 emailed the nk employee if a concomitant medical device was used.No reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the g5 monitor: bsm: model #: bsm-17xx.Serial #: (b)(6).Device manufacturer data: ni.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.
Event or Problem Description
Nk employee field support reported that the g5 monitoring unit was spontaneously rebooting.Not in patient use.
Event or Problem Description
Nk employee field support reported that the g5 monitoring unit was spontaneously rebooting.Not in patient use.
Additional Manufacturer Narrative
Details of the complaint: nk employee field support reported that the g5 monitoring unit was spontaneously rebooting.The unit was installed 2 months ago.Not in patient use.Investigation summary: during the evaluation of the device, we confirmed the reported issue was attributed to a software issue, (possibly due to either a user error, including a software installation setup/initialization error or an ungraceful exit, and/or a power issue that occurred during the installation process at the facility, possibly leading to corruption of the software).To resolve the issue, the software was reinstalled, and the device then met specifications, in all areas, and was returned to our used stock inventory.The customer was provided with a replacement device and guidance on the installation and setup process to immediately mitigate the issue.No further issues have been reported since.During the review of the history for the device (cu-151ra, serial number: (b)(6), this was the only complaint for this complaint device found in the past 3 (three) years.A similar issue at the facility, for a similar device was reported to us, under ticket #175906, for device cu-192ra, serial number (b)(6), during setup.However, a root cause was not determined, for ticket #175906, due to the customer's lack of responsiveness.These were the only 2 (two) similar issues for similar devices (under tickets 200142 and 175906) reported by the facility.Trending will continue to be monitored for the reported issue.The following field contains no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: (b)(6) 2024 emailed the nk employee if a concomitant medical device was used.No reply was received.Attempt # 2: (b)(6) 2024 emailed the nk employee if a concomitant medical device was used.No reply was received.Attempt # 3: (b)(6) 2024 emailed the nk employee if a concomitant medical device was used.No reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the g5 monitor: bsm: model #: bsm-17xx.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.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.H6 event problem and evaluation codes.H11 additional manufacturer narrative.

• Brand Name: CSM-1501
• 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: 18699745
• Report Number: 8030229-2024-04108
• Device Sequence Number: 7338402
• Product Code: MHX
• UDI-Device Identifier: 04931921002018
• UDI-Public: 04931921002018
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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: CSM-1501
• Device Catalogue Number: CSM-1501
• 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: 01/16/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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: BSM; BSM
• Patient Sex: Unknown