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

Model Number	BSM-3532A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the spo2 is intermittently working, and they are able to see that on the bedside monitor that the probe is no longer connected.The screen blanks out, and there is no error message displayed.He has stated that this has occurred with various different cables.He has also tried attaching different probes to see if the probes were the issue, and they were not.He has tested on multiple different bsm-3532.They stated that the cabling seems to be the issue with the connection rather than the probe.Not in patient use.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the spo2 is intermittently working, and they are able to see that on the bedside monitor that the probe is no longer connected.The screen blanks out, and there is no error message displayed.He has stated that this has occurred with various different cables.He has also tried attaching different probes to see if the probes were the issue, and they were not.He has tested on multiple different bsm-3532.They stated that the cabling seems to be the issue with the connection rather than the probe.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.
Additional Manufacturer Narrative
Details of the complaint: the biomedical engineer (bme) reported that the spo2 is intermittently working, and they are able to see that on the bedside monitor that the probe is no longer connected.The screen blanks out, and there is no error message displayed.He has stated that this has occurred with various different cables.He has also tried attaching different probes to see if the probes were the issue, and they were not.He has tested on multiple different bsm-3532.They stated that the cabling seems to be the issue with the connection rather than the probe.Not in patient use.Investigation conclusion: the cable, (jl-632p, serial number ni), was returned and evaluated.The cable was determined to be defective/damaged and was not working, which caused all the reported issues.We were able to confirm the reported issues were due to a defective/damaged cable, which can lead to communication / spo2 / display screen issues, as reported.Unfortunately, we were unable to determine a definitive root cause of how the cable became defective / damaged, as the issue is user dependent.However, it is likely that the cable became damaged/defective due to wear and tear over time.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 h7 h9 additional information: b4 date of this report 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 h10 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that the spo2 is intermittently working, and they are able to see that on the bedside monitor that the probe is no longer connected.The screen blanks out, and there is no error message displayed.He has stated that this has occurred with various different cables.He has also tried attaching different probes to see if the probes were the issue, and they were not.He has tested on multiple different bsm-3532.They stated that the cabling seems to be the issue with the connection rather than the probe.Not in patient use.

• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16660500
• Report Number: 8030229-2023-03423
• Device Sequence Number: 1700664
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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