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

Model Number	BSM-3552A
Medical Device Problem Code	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
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.
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
• MDR Report Key: 13197665
• Report Number: 2080783-2022-02281
• Device Sequence Number: 4404723
• Product Code: MHX
• UDI-Device Identifier: 04931921113677
• UDI-Public: 04931921113677
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/07/2022
• Report Date (Section F): 01/07/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/09/2021
• Device Age: 41 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/07/2022