MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CSM-1901; VITAL SIGNS MONITOR

Model Number CSM-1901

Device Problems Connection Problem (2900); Loss of Data (2903)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

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.Additional model information: concomitant medical device: the following device(s) was used in conjunction with the g9 monitor: bedside monitor:, model #: bsm-1753a, serial #: (b)(4), device manufacturer data: 01/01/2021, unique identifier (udi) #: (b)(4).Data acquisition unit: model #: ja-694pa, serial # : (b)(4), device manufacturer data: 01/01/2021, unique identifier (udi) #: (b)(4).

Event Description

The biomedical engineer (bme) reported that the g9 monitor connected to a bedside monitor (bsm) docked in a data acquisition unit (dau) had disconnected without any user input and the staff noticed that the patient data had been deleted.The bme reports that the transport monitor was set up in transport mode and should have been able to be undocked without the data being deleted.There was no harm or injury reported.Nihon kohden technician sent the bme a drop box link to collect the event logs.

Event Description

The biomedical engineer (bme) reported that the g9 monitor, connected to a bedside monitor (bsm), which was docked in a data acquisition unit (dau) had disconnected without user intervention, and the patient's data had disappeared.There was no harm or injury reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the g9 monitor, connected to a bedside monitor (bsm), which was docked in a data acquisition unit (dau) had disconnected without user intervention, and the patient's data had disappeared.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.A request for logs was made to the customer.However, the logs were not provided in a timely manner for proper analysis.Follow-ups with the customer for information were left unanswered.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 similar complaints.This event is likely an isolated incident.Nk will continue to monitor and trend similar complaints.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: a2 - a6 b6 b7 attempt # 1: 05/18/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/25/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 06/03/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: d10 concomitant medical device: the following devices were used in conjunction with the g9 monitor: bedside monitor: model #: bsm-1753a serial #: (b)(6) device manufacturer data: 01/01/2021 unique identifier (udi) #: (b)(4) data acquisition unit: model #: ja-694pa serial # : (b)(6) device manufacturer data: 01/01/2021 unique identifier (udi) #: (b)(4) 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 h10 additional manufacturer narrative.

• Brand Name: CSM-1901
• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 14595664
• MDR Text Key: 301079165
• Report Number: 8030229-2022-02890
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: 04931921112168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151080
• 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: 10/09/2023

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: CSM-1901
• Device Catalogue Number: CSM-1901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2020
• 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: BEDSIDE MONITOR; BEDSIDE MONITOR; DATA ACQUISITION UNIT (DAU); DATA ACQUISITION UNIT (DAU)