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

Model Number	BSM-3532A
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the bedside monitor (bsm) is spontaneously shutting down.Technical support (ts) informed the customer to have their biomed look at the device and have them reach out to troubleshoot.There was no patient injury 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 customer reported that the bedside monitor (bsm) is spontaneously shutting down.There was no patient injury reported.
Event or Problem Description
The customer reported that the bedside monitor (bsm) is spontaneously shutting down.There was no patient injury reported.
Additional Manufacturer Narrative
Details of complaint: the customer reported that the bedside monitor (bsm) is spontaneously shutting down.Technical support (ts) informed the customer to have their biomed look at the device and have them reach out to troubleshoot.There was no patient injury reported.Investigation summary: nihon kohden followed up with the customer, requesting additional information (on 05/08/23, 05/12/23, 05/17/23 and 05/22/23), however the customer did not respond, and no further information was reported.Due to the age of the complaint, and the customer's non-responsiveness to our follow up attempts, no further information was reported, and this complaint is being closed out.We were unable to confirm or determine a definitive root cause of the reported issue, (as the device was not returned for evaluation), and only limited information was reported, (due to the customer's non-responsiveness and the issue is user dependent).The following fields contain no information (ni), as attempts to obtain information were made, but not provided: attempt # 1: 06/12/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 2: 06/17/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 3: 06/22/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 1: 06/12/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 2: 06/17/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 3: 06/22/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 1: 06/12/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 2: 06/17/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 3: 06/22/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 1: 06/12/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 2: 06/17/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Attempt # 3: 06/22/2023 a phone call was made in an attempt to gather patient and device information; a voice mail was left for elizabeth to call me back with the patient and device information.Manufacturer references # (b)(4).

• 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: 17060457
• Report Number: 8030229-2023-03553
• Device Sequence Number: 8577588
• Product Code: MHX
• UDI-Device Identifier: 04931921113660
• UDI-Public: 04931921113660
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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