MAUDE Adverse Event Report: EPOCAL INC. EPOC BLOOD ANALYSIS SYSTEM; ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

Model Number	HH-1009-00-00
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer is alleging that siemens epoc device froze during patient testing.There was no report of injury due to this event.
Additional Manufacturer Narrative
The customer has been asked for more information and instrument files to complete investigation.The cause of this event is unknown.
Additional Manufacturer Narrative
Siemens has completed the investigation.The issue was able to be replicated by timing the ¿use this id¿ tap to coincide with a specific period of time while the results were being calculated.The cause of the issue is the timer used for ppid (positive patient id) was not updated to reflect a longer calculation period now required to calculate results.The consequence of a user tapping ¿use this id¿ during the specific window during calculation can lead to lost results due to the host freezing.

• Brand Name: EPOC BLOOD ANALYSIS SYSTEM
• Common Device Name: ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
• Manufacturer (Section D): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G3P 5; CA K1G3P5
• Manufacturer (Section G): EPOCAL INC.; 2060 walkley road; ottawa, ontario K1G 3 P5; CA K1G 3P5
• Manufacturer Contact: thomas myers ; 2 edgewater drive; norwood, MA 02062
• MDR Report Key: 16987023
• Report Number: 3002637618-2023-00033
• Device Sequence Number: 17833321
• Product Code: CHL
• UDI-Device Identifier: 00809708052898
• UDI-Public: 00809708052898
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2023

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
• Operator of Device: Health Professional
• Device Model Number: HH-1009-00-00
• Device Catalogue Number: 10736387
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female