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U.S. Department of Health and Human Services

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

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NIHON KOHDEN CORPORATION CSM-1901; VITAL SIGNS MONITOR Back to Search Results
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.
 
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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 Key19173967
MDR Text Key340946222
Report Number8030229-2024-04238
Device Sequence Number1
Product Code MHX
UDI-Device Identifier04931921112168
UDI-Public04931921112168
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151080
Number of Events Reported1
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 NumberCSM-1901
Device Catalogue NumberCSM-1901
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/29/2024
Initial Date FDA Received04/24/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/29/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
NI.
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