MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-3552A; VITAL SIGN MONITOR

Model Number	BSM-3552A
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) will display spo2, and then all of a sudden, it will stop displaying as if there is no cable plugged in.There are no error messages on the bsm when this occurs.They replaced the finger probe and the trunk cable, but the issue follows this bsm.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.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) will display spo2, and then all of a sudden, it will stop displaying as if there is no cable plugged in.There are no error messages on the bsm when this occurs.They replaced the finger probe, and the trunk cable, but the issue follows this bsm.No patient harm reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) would display spo2; and then suddenly stop displaying it, appearing as if no cable was plugged in.There were no error messages on the bsm when this occured.They replaced the finger probe and the trunk cable, but the issue follows this bsm.Service requested / performed: evaluation / repair.Investigation summary: nk repair center could not duplicate the issue of intermittent spo2 readings.As such root cause cannot be determined.It is likely that the customer was using a defective spo2 cable at the time of the incident.The spo2 cable was not returned with the bsm for evaluation.Cable damage is likely the cause of intermittent readings as the customer reported they had not tested with a different cable or probes.The device was returned to the customer.No further issues were reported and this issue had not recurred with the reported device.The issue is most likely resolved.
Event or Problem Description
The biomedical engineer (bme) reported that the bedside monitor (bsm) would display spo2; and then suddenly stop displaying it, appearing as if no cable was plugged in.There were no error messages on the bsm when this occured.

• Brand Name: BSM-3552A
• Common Device Name: VITAL SIGN 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; mgmt seibu bldg 2, 4th floor 1; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10936092
• Report Number: 8030229-2020-00722
• Device Sequence Number: 19008488
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: 04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 11/10/2022

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-3552A
• Device Catalogue Number: BSM-3552A
• 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: 11/03/2020
• Supplement Date Received by Manufacturer: 08/26/2022
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2019
• 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
• Patient Sex: Unknown