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

Model Number CSM-1901

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

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

Event Date 03/29/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this unit shut off and stopped working while in use.The customer tried a new power cable and the issue remained.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: attempt # 1: 04/10/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/17/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i cannot provide the requested information.B6 attempt # 1: 04/10/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/17/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i cannot provide the requested information.B7 attempt # 1: 04/10/2024 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 04/17/2024 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i cannot provide the requested information.D10 attempt # 1: 04/10/2024 emailed the customer via microsoft outlook for device information: no reply was received.Attempt # 2: 04/17/2024 emailed the customer via microsoft outlook for device information: the customer replied by stating; i cannot provide the requested information.

Event Description

The customer reported that this unit shut off and stopped working while in use.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: 19173967
• MDR Text Key: 340946222
• Report Number: 8030229-2024-04238
• 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
• Report Date: 04/24/2024

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: CSM-1901
• Device Catalogue Number: CSM-1901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2020
• 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: NI.