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

Model Number CSM-1901

Device Problem Pumping Problem (3016)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their nicu patient is showing marks on their arms and legs after multiple nibp attempts by this core unit (g9).No further information of this event was provided.

Event Description

The customer reported that their nicu patient is showing marks on their arms and legs after multiple nibp attempts by this core unit (g9).No further information of this event was provided.

• 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
• MDR Report Key: 12247568
• MDR Text Key: 267086639
• Report Number: 2080783-2021-01436
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: 04931921112168
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/29/2021

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2021
• Distributor Facility Aware Date: 06/29/2021
• Device Age: 63 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other