MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-1733A; VITAL SIGNS MONITOR

Model Number BSM-1733A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the bedside monitor is not displaying the electrocardiogram (ecg), the unit is not showing any information.The customer will send in the unit to be repaired.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.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6: attempt# 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have any information.B6: attempt # 1: attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have any information.B7: attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have any information.D10: attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i don't have any information.

Event Description

The customer reported that the bedside monitor is not displaying the electrocardiogram (ecg), the unit is not showing any information.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the bedside monitor is not displaying the electrocardiogram (ecg), the unit is not showing any information.The customer will send in the unit to be repaired.There was no patient injury reported.Investigation summary: nihon kohden (nk) received the complaint device on 05/31/2023.The nk repair center (rc) evaluated the device on 06/20/2023.The nk rc duplicated the complaint and observed the device showing an ecg module error message.The bsm software was upgraded and the ecg and spo2 circuit boards were replaced to repair the device.The spo2 board was replaced to maintain firmware compatibility.The cause of the issue was failure of the ecg board.Attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have any information.B6 attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have any information.B7 attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i don't have any information.D10 attempt # 1: 05/12/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i don't have any information.Manufacturer references # (b)(4).

Event Description

The customer reported that the bedside monitor is not displaying the electrocardiogram (ecg), the unit is not showing any information.There was no patient injury reported.

• Brand Name: BSM-1733A
• Type of Device: 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 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: 17062243
• MDR Text Key: 317658967
• Report Number: 8030229-2023-03559
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921111833
• UDI-Public: 4931921111833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/06/2023

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
• Device Operator: Health Professional
• Device Model Number: BSM-1733A
• Device Catalogue Number: BSM-1733A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 09/05/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NI.; NI.