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

Model Number BSM-1733A

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) was not giving the correct ecg readings.This was discovered during preventative maintenance and was not in patient use.

Manufacturer Narrative

The biomedical engineer (bme) reported that the bedside monitor (bsm) was not giving the correct ecg readings.This was discovered during preventative maintenance and was not in patient use.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 contains no information (ni), as an attempt to obtain the information was made, but not provided.D10 attempt # 1: 11/20/2023 emailed the bme for all items under the no information list: no reply was received.Attempt # 2: 11/27/2023 emailed the bme for all items under the no information list: no reply was received.Attempt # 3: 12/04/2023 emailed the bme for all items under the no information list: no reply was received.

Event Description

The biomedical engineer (bme) reported that the bedside monitor (bsm) was not giving the correct ecg readings.This was discovered during preventative maintenance and was not in patient use.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) was not giving the correct ecg readings.This was discovered during preventative maintenance and was not in patient use.Investigation summary: we were unable to confirm the reported issue, as the device was never returned to nihon kohden (nk).Three good faith efforts (gfes) were made to the customer with no response.As such, a definitive root cause could not be determined.Based on the available information, the most probable root cause could have been lead placement, contaminated leads, or a faulty ecg port.However, due to the unit not being returned to nk, we were unable to confirm the reported issue.An exchange input unit was shipped to the customer to resolve the issue.An overview of other input unit failure errors and other potential causes is detailed below.Improperly placed or faulty leads can cause inaccurate ecg readings, including fuzzy waveforms or artifacts like signal noise.Users should verify that the leads are approved for use with the bsm they are operating before monitoring a patient.Users should ensure all cable connections are secure and that the leads are not damaged or contaminated.Damage to the conductive wires in the leads can prevent data from reaching the bsm and transferring over to the cns.Residue buildup on contact points could create a weak signal or a flat line on the bsm or cns.If any of these issues occur, the user should recognize them promptly.These factors can also cause missing numerics or numerics with no waveforms, missing expanded waveforms, or waveforms that appear cut off.A serial number review of the reported device (bsm-1733a, serial number 8368) does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.The following field contains no information (ni), as an attempt to obtain the information was made, but not provided.D10 attempt # 1: 11/20/2023 emailed the bme for all items under the no information list: no reply was received.Attempt # 2: 11/27/2023 emailed the bme for all items under the no information list: no reply was received.Attempt # 3: 12/04/2023 emailed the bme for all items under the no information list: no reply was received.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.H11 additional manufacturer narrative.

• 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: 18283381
• MDR Text Key: 329948305
• Report Number: 8030229-2023-03949
• 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: 03/08/2024

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-1733A
• Device Catalogue Number: BSM-1733A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2020
• 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