MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6301A; VITAL SIGNS MONITOR

Model Number BSM-6301A

Device Problems Signal Artifact/Noise (1036); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/28/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the loaner bedside monitor (bsm) has a lot of noise on the ecg (electrocardiograph) readings while monitoring a patient.No patient harm was reported.Bme reported that they did switch out the cables and when they disconnected the transport unit from the main unit the transport unit ecg waves read fine, but as soon as it is plugged into the main bsm unit the noise comes back.Biomed requested to have another loaner sent out to their facility.

Manufacturer Narrative

The biomedical engineer (bme) reported that the loaner bedside monitor (bsm) has a lot of noise on the ecg (electrocardiograph) readings while monitoring a patient.No patient harm was reported.Bme reported that they did switch out the cables and when they disconnected the transport unit from the main unit the transport unit ecg waves read fine, but as soon as it is plugged into the main bsm unit the noise comes back.Biomed requested to have another loaner sent out to their facility.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 are not applicable (na) to the mdr report: b2 d4 lot number & expiration d6a - d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 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: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: no reply was received.Attempt # 2: (b)(6) 2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received and biomed could not provide the requested information.

Manufacturer Narrative

Incident summary: the biomedical engineer (bme) reported that the loaner bedside monitor (bsm) has a lot of noise on the ecg (electrocardiograph) readings while monitoring a patient.No patient harm was reported.Bme reported that they did switch out the cables and when they disconnected the transport unit from the main unit the transport unit ecg waves read fine, but as soon as it is plugged into the main bsm unit the noise comes back.Biomed requested to have another loaner sent out to their facility.Investigation summary: upon evaluation from repair center, there was damage to the inside of the front enclosure and damage to the main chassis.Additionally, there was a light bleeding on the right side of the lcd screen.However, whentested the unit did not have any noise on the ecg readings.As such, a definitive root cause was not determined.Based on the available information it is likely the device had noise on the ecg readings could have been caused either by the physical damage(s) to the unit, or the customer was using incorrect cables when taking an ecg reading.Users should verify that the leads are authorized for use with the bsm in operation before monitoring a patient.Improper connection of leads (leads not properly seated), and/or damaged or contaminated leads (dirt, dust and/or cleaning residues) may contribute to ecg issues.A serial number review of the reported device (mu-631ra, serial number 17782) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.01/16/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received and biomed could not provide the requested information.Additional information: b4 date of this report 04/26/2024 d9 is this device available for evaluation? yes returned to manufacturer 04/25/2024 g3 date received by manufacturer 04/25/2024 g6 type of report follow-up h2 if follow-up, what type? additional information, device evaluation h3 device evaluated by manufacturer? yes h6 adverse event problem codes, 10, 213, 4248, 19 & 61.

Event Description

The biomedical engineer (bme) reported that the loaner bedside monitor (bsm) has a lot of noise on the ecg (electrocardiograph) readings while monitoring a patient.No patient harm was reported.Bme reported that they did switch out the cables and when they disconnected the transport unit from the main unit the transport unit ecg waves read fine, but as soon as it is plugged into the main bsm unit the noise comes back.Biomed requested to have another loaner sent out to their facility.

• Brand Name: BSM-6301A
• 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 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: 18548369
• MDR Text Key: 333511267
• Report Number: 8030229-2024-04054
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921103517
• UDI-Public: 04931921103517
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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-6301A
• Device Catalogue Number: MU-631RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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.