MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION BSM-6701A; VITAL SIGN MONITOR

Model Number	BSM-6701A
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the the bedside monitor (bsm) stopped showing ecg data while in patient use.No reports of patient harm or injury.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the bedside monitor (bsm) stopped showing ecg data while in patient use.They tried changing the ecg cables, the leads, and electrodes and repositioned the ecg placements.Bme also swapped out the input unit, but the bsm continued to give a "check electrodes" error message, with no ecg data coming through.No reports of patient harm or injury.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, b6, b7, d10.Attempt # 1: 05/30/2023 emailed bme for the patient information and the concomitant medical device: no reply was received.Attempt # 2: 06/02/2023 emailed bme for the patient information and the concomitant medical device: no reply was received.Attempt # 3: 06/08/2023 emailed bme for the patient information and the concomitant medical device: no reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm (bsm-6701a): input unit model #: bsm-1700; serial #: ni; device manufacturer data: ni; unique identifier (udi) #: ni; returned to nihon kohden: na.
Event or Problem Description
The biomedical engineer (bme) reported that the the bedside monitor (bsm) stopped showing ecg data while in patient use.No reports of patient harm or injury.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the bedside monitor (bsm) stopped showing ecg data while in patient use.They tried changing the ecg cables, the leads, and electrodes and repositioned the ecg placements.Bme also swapped out the input unit, but the bsm continued to give a "check electrodes" error message, with no ecg data coming through.No reports of patient harm or injury.Investigation summary: the root cause could not be determined for the issue of no ecg data due to the customer not responding to good faith efforts.The device was not returned, and the issue could not be confirmed.Possible causes may be related to hardware failure of the ecg module of the bedside monitor.Hardware failure could result from physical, heat, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.The device was installed in (b)(6) 2018.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.Attempt # 1: (b)(6) 2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 2: (b)(6) 2023 emailed the bme for all items under the no information list.No reply was received.Attempt # 3: (b)(6) 2023 emailed the bme for all items under the no information list.No reply was received.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the bsm (bsm-6701a): input unit.Model #: bsm-1700.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.

• Brand Name: BSM-6701A
• Common Device Name: VITAL SIGN 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: 17140701
• Report Number: 8030229-2023-03610
• Device Sequence Number: 13930183
• Product Code: MHX
• UDI-Device Identifier: 04931921103562
• UDI-Public: 04931921103562
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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-6701A
• Device Catalogue Number: MU-671RA
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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: BSM-1700 (INPUT UNIT); BSM-1700 (INPUT UNIT)
• Patient Sex: Unknown