MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION LIFE SCOPE TR; VITAL SIGNS MONITOR (BSM-6500 MAIN UNIT)

Model Number	MU-651RA
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported having trouble seeing the "art-line" on the patient's bedside monitor (bsm).According to the customer, they can only see the art line when they select the waveform; they can see the waveform on the central nurse's station (cns).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.
Event or Problem Description
The customer reported having trouble seeing the "art-line" on the patient's bedside monitor (bsm).There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported having trouble seeing the "art-line" on the patient's bedside monitor (bsm).They could only see the art line when selecting the waveform, but they were able to see the waveform at the central nurse's station (cns).No patient harm or injury was reported.Investigation summary: due to the age of the complaint, additional information is unlikely to be made available.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal similar complaints.Possible causes of not seeing the art line may be related to improper cable connection or incorrect labelling of the cable on the monitor.Attempt # 1: 05/19/2022 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: 05/26/2022 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 3 06/02/2022 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: cns: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: ni.
Event or Problem Description
The customer reported having trouble seeing the "art-line" on the patient's bedside monitor (bsm).There was no patient injury reported.
Additional Manufacturer Narrative
Udi related data quality updates corrected information: d1 brand name: corrected the brand name from bsm-6501a to life scope tr.D4 additional device information / model #: corrected the model # from bsm-6501a to mu-651ra.D4 additional device information / primary unique device identifier (udi) #: corrected the udi # to include the pi information.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.Additional information: b4 data of this report.G6 type of report.H2 if follow up, what type?.
Event or Problem Description
The customer reported having trouble seeing the "art-line" on the patient's bedside monitor (bsm).There was no patient injury reported.

• Brand Name: LIFE SCOPE TR
• Common Device Name: VITAL SIGNS MONITOR (BSM-6500 MAIN UNIT)
• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14639533
• Report Number: 8030229-2022-02897
• Device Sequence Number: 17536597
• Product Code: MHX
• UDI-Device Identifier: 04931921103548
• UDI-Public: (01)04931921103548(21)5118
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2024

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: MU-651RA
• Device Catalogue Number: MU-651RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 11/02/2023; 11/02/2023
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 11/07/2023; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2019
• 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: CNS; CNS; CNS
• Patient Sex: Unknown