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

Model Number	MU-671RA
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer emailed to report that their bedside monitor (bsm) would shut down while in patient use and display multiple errors before booting back on again.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 device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: bedside monitor: model #: bsm-1773; serial #: (b)(6).Device manufacturer data: 12/19/2018 (dec.19, 2018); unique identifier (udi) #:(b)(4).Returned to nihon kohden: not returned.
Event or Problem Description
The customer emailed to report that their bedside monitor (bsm) would shut down while in patient use and display multiple errors before booting back on again.No patient harm was reported.
Event or Problem Description
The customer emailed to report that their bedside monitor (bsm) would shut down while in patient use and display multiple errors before booting back on again.No patient harm was reported.
Additional Manufacturer Narrative
The customer emailed to report that their bedside monitor (bsm) would shut down while in patient use and display multiple errors before booting back on again.No patient harm was reported.The complaint device was received by nihon kohden.The unit was evaluated and the complaint could not be duplicated.The unit was found with extensive damage.Due to the damage found, the cause of the issue was likely hardware component failure of the main board and other components due to physical damage from user mishandling.The unit could not be repaired and an exchange was recommended instead.Nk will continue to monitor and trend similar complaints additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: bedside monitor: model #: bsm-1773 serial #: (b)(6).Device manufacturer data: 12/19/2018 (dec.19, 2018) unique identifier (udi) #:(b)(4).Returned to nihon kohden: not returned 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: LIFE SCOPE TR
• 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: 21583544
• Report Number: 8030229-2025-04722
• Device Sequence Number: 9467890
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: (01)04931921103562
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K080342
• 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): 05/05/2025

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: MU-671RA
• Device Catalogue Number: MU-671RA
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2017
• 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-1773.; BSM-1773.
• Patient Sex: Unknown