MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3532A; VITAL SIGNS MONITOR

Model Number	BSM-3532A
Medical Device Problem Codes	No Audible Alarm (1019); Alarm Not Visible (1022); Protective Measures Problem (3015)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the alarms were turned off at the bsm, but the nurse is stating that they did not do that.They are thinking the alarms were turned off around 4:30pm est on 6/15/20.Therefore, the hospital management would like this investigated.We have not yet received the logs to investigate this issue, so it is unclear at this time whether it was turned off by the user, or if this was a device failure.Therefore, to err on the side of caution this is being reported.No patient harm 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: concomitant medical device: the following devices were being used in conjunction with the bedside monitor.Central nurse's station: model: cns-6201a.Sn: (b)(4).
Event or Problem Description
The biomedical engineer (bme) reported that the alarms were turned off at the bsm, but the nurse is stating that they did not do that.They are thinking the alarms were turned off around 4:30pm est on (b)(6) 2020.Therefore, the hospital management would like this investigated.We have not yet received the logs to investigate this issue, so it is unclear at this time whether it was turned off by the user, or if this was a device failure.Therefore, to err on the side of caution this is being reported.No patient harm reported.
Event or Problem Description
The biomedical engineer (bme) reported that the alarms were turned off at the bsm, but the nurse was stating they did not turn them off.The hospital management would like this investigated.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the alarms were turned off at the bsm, but the nurses were stating they did not turn them off.The hospital management wanted to have this investigated.No patient harm or injury was reported.Investigation summary: device logs were analyzed, and additional information was requested.However, additional information was not provided.There was insufficient information provided at the time of the event to determine the root cause.There is no indication that the device had malfunctioned.The service history for this serial number shows no subsequent reported events related to alarm.

• Brand Name: BSM-3532A
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10261297
• Report Number: 8030229-2020-00374
• Device Sequence Number: 2655075
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• 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
• Report Date (Section B): 03/03/2023
• Report Date (Section F): 07/10/2020

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-3532A
• Device Catalogue Number: BSM-3532A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/17/2020
• Device Age: 40 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2017
• 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: CNS-6201A SN (B)(6); CNS-6201A SN (B)(6)
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/10/2020