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

Model Number	BSM-3532A
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/06/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer reported that one of their patients experienced a fatal rhythm that the bedside monitor (bsm) did not pick up.The ecg print out suggest a faster rate without a documented crisis alarm.The documentation also reveals a low mv for the patient hr.However, arrhythmia alarms did capture an "irregular rr".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.The following field(s) contain no information (ni), as attempts to obtain information were made, but not provided: attempt #1: 12/22/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 12/29/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 01/05/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: concomitant medical device: the following device was used in conjunction with the bsm: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni.
Event or Problem Description
The customer reported that one of their patients experienced a fatal rhythm that the bedside monitor (bsm) did not pick up.The ecg print out suggest a faster rate without a documented crisis alarm.The documentation also reveals a low mv for the patient hr.However, arrhythmia alarms did capture an "irregular rr".
Additional Manufacturer Narrative
Details of complaint: the customer reported that one of their patients experienced a fatal rhythm that the bedside monitor (bsm) did not pick up.The ecg printout suggested a faster rate without a documented crisis alarm.The documentation also revealed a low hr mv.However, arrhythmia alarms did capture an irregular rr.Investigation summary: as no devices were returned and no logs were provided for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Due to the age of the complaint, additional information is unlikely to be available.The customer reported that the alarm missed was logged into the arrhythmia recall but did state there was no audible alarm.The customer providing this information was using the secondary monitoring source and could not provide information regarding the primary monitoring station.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Possible causes may be related to patient condition, the use of faulty leads, or improper patient prep.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6.B6.B7.D10.Attempt #1: 12/22/2021, emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 12/29/2021, emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 01/05/2022, emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm: cns: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.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.
Event or Problem Description
The customer reported that one of their patients experienced a fatal rhythm that the bedside monitor (bsm) did not pick up.The ecg printout suggested a faster rate without a documented crisis alarm.The documentation also revealed a low hr mv.However, arrhythmia alarms did capture an irregular rr.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 13170656
• Report Number: 8030229-2022-02273
• Device Sequence Number: 19949649
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL NURSE'S STATION (CNS); CENTRAL NURSE'S STATION (CNS)
• Outcome Attributed to Adverse Event: Death; Death
• Patient Sex: Unknown