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

Model Number	27803
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
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.
Event or Problem Description
The customer reported that the emma provided high values.No consequences or impact to patient were reported.
Event or Problem Description
The customer reported that the emma provided high values.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated and passed functional testing.During accuracy testing, the unit measured outside of the specification.A zeroing calibration was performed and the following measured value was within accuracy specification.Incorrect zeroing results in co2 measurements outside the accuracy specification.Performing zeroing restored accuracy.A service history record review reveals that this unit was in the field for over eleven (11) months with no previous reported issues related to this reported event.

• Brand Name: EMMA (MMHG) CAPNOGRAPH KIT
• Common Device Name: OXIMETER
• MDR Report Key: 12328315
• Report Number: 3011353843-2021-00201
• Device Sequence Number: 11469572
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 27803
• Device Catalogue Number: 3639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• 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
• Patient Age: 33 YR