MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr" was confirmed based on the review of the archive data and during functional testing.The apvision software was used to clear the system error message.However, as a precautionary measure, the processor board was replaced as there may have had some intermittent issue that could not be directly identified during the functional testing.The autopulse platform was manufactured in 2015 and is 8 years old, past the expected service life of 5 years.Visual inspection of the returned platform was performed, and no physical damage was observed.The power distribution board revision was up to date and the brake gap was within specification.The archive data review showed the occurrence of system error - 132 (internal watchdog timeout), thus confirming the reported complaint.Unrelated to the reported complaint, several fault 41 (patient temperature sensor failure) were observed.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device, thus, confirming the reported complaint.The apvision software was used to clear the system error message.The processor board was replaced as a precautionary measure.The fault 41 observed in the archive was not reproduced.However, the temperature sensor was proactively replaced, as the sensor may have had some intermittent technical problems that could not be directly identified during the functional testing.Following service, the autopulse platform passed the run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse with serial number (b)(6).
Event or Problem Description
During shift check, the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr." no patient involvement.
Additional Manufacturer Narrative
**udi related data quality updates only**.

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17896022
• Report Number: 3010617000-2023-00844
• Device Sequence Number: 15198599
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2015
• 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: Unknown