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

Model Number	BSM-3532
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that the bedside monitor (bsm) is rebooting itself with no user intervention.The nurse reported that a blue screen pops up and then a line of text with binary numbers on it.The device is not on the network so it is not a network loop.No patient harm was reported.
Additional Manufacturer Narrative
A nurse reported that the bedside monitor (bsm) is rebooting itself with no user intervention.The nurse reported that a blue screen pops up and then a line of text with binary numbers on it.The device is not on the network so it is not a network loop.No patient harm was 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.
Additional Manufacturer Narrative
Details of complaint: the nurse reported that the device rebooted on its own and that a blue screen popped up, displaying lines of binary numbers.The device is not on the network, so it could not be a network loop.There was no patient injury reported.Investigation summary: the reported device was sent in for evaluation and repair.The reported issue could not be duplicated.The results of the evaluation showed that this complaint is not confirmed.As such, a definitive root cause of the reported issue could not be determined.No further investigation will be performed.Nk will continue to monitor and trend for this issue.The following field(s) contain no information (ni), as attempts to obtain the information were made, but not provided: d10 attempt # 1: 03/26/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 04/03/2025 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3: 04/04/2025 emailed the customer via microsoft outlook for all information in the ni list above: 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? h6 event problem and evaluation codes h11 additional manufacturer narrative.
Event or Problem Description
The nurse reported that the device rebooted on its own and that a blue screen popped up, displaying lines of binary numbers.The device is not on the network, so it could not be a network loop.There was no patient injury reported.

• Brand Name: LIFE SCOPE VS
• 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: 21780803
• Report Number: 8030229-2025-04814
• Device Sequence Number: 15401176
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: (01)04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201949
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: BSM-3532
• Device Catalogue Number: BSM-3532A
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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