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

Model Number	BSM-3552A
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that their bedside monitor (bsm) is showing incorrect ecg readings.They clarified that the bedside was falsely alarmed for tachycardia, but when they moved the patient to another unit, they realized that the previous reading was incorrect.No harm or injury occurred.
Event or Problem Description
The customer reported that the bedside monitor (bsm) was showing incorrect ecg readings.They clarified that the bsm falsely alarmed for tachycardia, but when they moved the patient to another unit, they realized the previous reading was incorrect.No harm or injury occurred.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the bedside monitor (bsm) was showing incorrect ecg readings.They clarified that the bsm falsely alarmed for tachycardia, but when they moved the patient to another unit, they realized the previous reading was incorrect.No patient harm or injury was reported.Investigation summary: nihon kohden (nk) was unable to confirm the reported issue, based on the available information.A root cause cannot be determined, as the issue is user dependent.After nk followed up with the customer, it was reported that the issue was resolved, and no further details were provided on how the issue was resolved.As the issue was resolved without nk assistance, it is unlikely that the issue occurred due to an nk device malfunction.No further issues related to ecg issues or incorrect values were reported for this device.The root cause is likely related to clinical education, due to the nature of the complaint.Variables such as lead placement and patient preparation are known to affect ecg readings.During a review of the complaint device history and facility trending, it was determined that this was an isolated incident, as this was the only complaint found for this device and facility in the past 3 (three) years.As such, a significant trend that would warrant any action and/or corrective action was not identified.The following fields contain no information (ni), as an attempt to obtain information was made, but was not provided: a2 - a6 b6 - b7 attempt #1 01/06/2022 emailed customer via microsoft outlook for all items under the no information section.The customer replied stating that the issue was resolved.No further information was provided.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h10 additional manufacturer narrative.

• 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 ; 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: 13197667
• Report Number: 8030229-2022-02281
• Device Sequence Number: 11863223
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: 04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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-3552A
• Device Catalogue Number: BSM-3552A
• 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: 12/09/2021
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2018
• 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