MAUDE Adverse Event Report: DISPO-MED MEDSOURCE LABS; CAPNOGRAPHY

Model Number	MS-35601A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Customers are reporting the product is not giving accurate readings.

• Brand Name: MEDSOURCE LABS
• Common Device Name: CAPNOGRAPHY
• Manufacturer (Section D): DISPO-MED
• Manufacturer Contact: cecilia ngwan ; MY
• MDR Report Key: 24570851
• Report Number: 3003674698-2026-00204
• Device Sequence Number: 21186605
• Product Code: CCK
• UDI-Device Identifier: 00840155408944
• UDI-Public: 00840155408944
• Combination Product (Y/N): N
• PMA/510(K) Number: K143127
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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
• Operator of Device: Health Professional
• Device Model Number: MS-35601A
• Device Catalogue Number: MS-35601A
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown