MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE VS; BEDSIDE MONITOR, LOW ACUITY, NK SPO2

Model Number	BSM-3572
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	10/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The nihon kohden employee reported that the bedside monitor (bsm) will beep loudly 3 times, and the entire screen goes blue with white letters.It boot loops without input.This was 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 fields are not applicable (na) to the mdr report: a2 - a6 b2 b6 - b7 d4 lot number & expiration d6a - d6b d7b d10 concomitant medical device f1 - f14 g4 device bla number g5 g7 h2 h7 h9.
Event or Problem Description
The nihon kohden employee reported that the bedside monitor (bsm) will beep loudly 3 times, and the entire screen goes blue with white letters.It boot loops without input.This was not in patient use.
Additional Manufacturer Narrative
Details of the complaint: the nihon kohden employee reported that the bedside monitor (bsm) will beep loudly 3 times, and the entire screen goes blue with white letters.It boot loops without input.This was not in patient use.Investigation conclusion: nk tech support reviewed a video from nk account executive and saw that the bsm displayed a fatal error.Ts recommended re-installing the software to fix the issue.The software was sent to nk ae who stated that the issue was resolved after loading the software onto the bsm.According to the bsm-3000 service manual, fatal error is a system error detected in the operating system (os).Based on the resolution details, possible cause was likely software corruption which can occur through user error when updating software or transferring files from the memory card, or sudden power loss from ungraceful shutdown or power supply issues.
Event or Problem Description
The nihon kohden employee reported that the bedside monitor (bsm) will beep loudly 3 times, and the entire screen goes blue with white letters.It boot loops without input.This was not in patient use.
Additional Manufacturer Narrative
Udi related data quality updates.Corrected information: d1 brand name: corrected the brand name from bsm-3572a to life scope vs.D4 additional device information / model #: corrected the model # from bsm-3572a to bsm-3572.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the production identifier (pi) information.G4 premarket identification / pma/510(k) number: corrected the 510(k) # from k080342 to k201949.This is a correction to the suspect medical device involved in the reported event, specifically the unique device identifier (udi) information in section d of the fda form 3500a.
Event or Problem Description
The nihon kohden employee reported that the bedside monitor (bsm) will beep loudly 3 times, and the entire screen goes blue with white letters.It boot loops without input.This was not in patient use.

• Brand Name: LIFE SCOPE VS
• Common Device Name: BEDSIDE MONITOR, LOW ACUITY, NK SPO2
• 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: 18156821
• Report Number: 8030229-2023-03868
• Device Sequence Number: 12402012
• Product Code: MHX
• UDI-Device Identifier: 04931921113691
• UDI-Public: (01)04931921113691
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

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: BSM-3572
• Device Catalogue Number: BSM-3572A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 02/14/2024; 02/14/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 02/15/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2021
• 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