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	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the autopulse platform (sn 40664) displayed "system error, out of service, revert to manual cpr " error message immediately upon powering on.Also the upper case is broken.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) displayed "system error, out of service, revert to manual cpr " error message was confirmed based on the review of the archive data and during functional testing.The root cause of the reported complaint was the failed processor board, likely attributed to the aging of the device.The autopulse platform was manufactured in 2012 and is over 11 years old, past its expected service life of 5 years.The secondary complaint of a broken upper case was confirmed during visual inspection.The top cover was observed to be cracked/damaged.The observed physical damage appeared to be the characteristics of harsh impacts due to user mishandling.Top cover was replaced to remedy the issue.During further visual inspection of the platform, no other physical damage was observed.The archive data review showed the occurrence of system error - 132 (internal watchdog timeout), thus confirming the reported complaint.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.Therefore, the reported complaint was confirmed.The processor board (pca) was replaced to remedy the system error.Upon service completion, the platform will be subjected to final functional testing to ensure that the device passes all testing criteria.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).
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: 17978094
• Report Number: 3010617000-2023-00920
• Device Sequence Number: 3568393
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/24/2024

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2023
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2012
• 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