MAUDE Adverse Event Report: EMMA (MMHG) CAPNOGRAPH KIT; OXIMETER

Model Number	18265
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted., (b)(6).
Event or Problem Description
The customer reported the device works intermittently, does not recognize when adapter is moved.No patient impact or consequences were reported.
Additional Manufacturer Narrative
Other, other text: the returned device was investigated.Visual inspection found the detector lens is recessed.The unit powered on and off using battery power but the device triggers a clogged adapter error when the airway adapter is installed.A red error light flashes on the display when this error is present.The clogged adapter error is due to the recessed detector lens.A service history record review reveals that this unit was in the field for over four (4) years with no previous reported issues related to this reported event.Initial reporter phone number exceeded the maximum allowable characters, phone number is as follows: (b)(6).
Event or Problem Description
The customer reported the device works intermittently, does not recognize when adapter is moved.No patient impact or consequences were reported.

• Brand Name: EMMA (MMHG) CAPNOGRAPH KIT
• Common Device Name: OXIMETER
• MDR Report Key: 12492447
• Report Number: 3011353843-2021-00245
• Device Sequence Number: 20509020
• Product Code: CCK
• UDI-Device Identifier: 07350046131750
• UDI-Public: 07350046131750
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: 18265
• Device Catalogue Number: 3639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/17/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1