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

Model Number CSM-1901

Device Problems Loss of Data (2903); Data Problem (3196)

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

Event Date 04/22/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this g9 is discharging patients on its own.According to the customer, the unit will discharge and then they're having to readmit the patient.Per the customer, this happened multiple times with this unit.The customer requested for nk to look at the logs from the g9 and the central nurse's station (cns).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: 05/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/08/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 05/12/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide any patient information.Attempt # 1: 05/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/08/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 05/12/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide any patient information.B7 attempt # 1: 05/01/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 05/08/2023 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 05/12/2023 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i am unable to provide any patient information.D10 attempt # 1: 05/01/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 05/08/2023 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 3 05/12/2023 emailed the customer via microsoft outlook for device information: the customer replied by stating; i am unable to provide any patient information.

Event Description

The customer reported that this g9 is discharging patients on its own.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this g9 is discharging patients on its own.According to the customer, the unit will discharge and then they're having to readmit the patient.Per the customer, this happened multiple times with this unit.The customer requested for nk to look at the logs from the g9 and the central nurse's station (cns).The customer will send in the unit to be repaired.There was no patient injury reported.Investigation summary: review of the logs confirmed that the cns operation at ip address 10.103.39.226 had discharged g9.Since the cns with ip address 10.103.39.44 is also present, it is possible that the "discharge" operation was performed from another cns (10.103.39.226), which may have been recognized as "discharge" performed on its own.Manufacturer references # (b)(4) - 171351 follow up 001.

Event Description

The customer reported that this g9 is discharging patients on its own.There was no patient injury reported.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 16969519
• MDR Text Key: 316439583
• Report Number: 8030229-2023-03522
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

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: 04/22/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• 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: CNS; CNS