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.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.Attempt #1 :07/14/2021 emailed customer via (b)(6) for all items under the no information section.No reply was received.Attempt #2: 07/21/2021 emailed customer via (b)(6) for all items under the no information section.No reply was received.Attempt #3: 07/29/2021 emailed customer via (b)(6) for all items under the no information section.No reply was received.

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.

Manufacturer Narrative

Details of complaint: the customer reported that the nicu patient being monitoring on the core unit (g9 monitor) was showing marks on their arms and legs after multiple attempts to get nibp readings.No further information of this event was provided.Investigation summary: as no devices were returned and no pictures were submitted for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.As the nibp cuff inflates, it is possible that the cuff would leave marks on a patient's arm or leg should the cuff become too tight.Possible causes for this are overinflating and using the incorrect sized cuff on the patient.Due to the age of the complaint, additional information is unlikely to be available.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.The root cause is likely to be related to the use of an incorrect cuff size.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt #1 07/14/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 07/21/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 07/29/2021 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The customer reported that the nicu patient being monitoring on the core unit (g9 monitor) was showing marks on their arms and legs after multiple attempts to get nibp readings.

• 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: 12247544
• MDR Text Key: 264297569
• Report Number: 8030229-2021-01436
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: 04931921112168
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/25/2023

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: 06/29/2021
• Initial Date FDA Received: 07/29/2021
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• 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
• Patient Outcome(s): Other