MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Codes	Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During preventative maintenance (pm) performed on april 08, 2024, the autopulse platform (sn (b)(6) failed the load cell characterization test and the backlight of the platform's lcd flickered briefly upon powering on and went dark afterward.No patient involvement.
Additional Manufacturer Narrative
During preventative maintenance (pm) performed on april 08, 2024, the autopulse platform (sn (b)(6) failed the load cell characterization test and the backlight of the platform's lcd flickered briefly upon powering on and went dark afterward.The root cause of failed load cell characterization test was due to a failure of load cell module #1, likely attributed to the age of the platform, failed component(s), or mishandling such as a drop.The root cause for the lcd issue was a failed processor board, likely attributed to the age of the device.The autopulse platform was manufactured in 2009 and is over 15 years old, past its expected service life of 5 years.Upon visual inspection, the backlight of the display flickers briefly when switched on and is dark afterwards.The processor board will be replaced to remedy the issue.The autopulse passed the initial functional test without any fault or error.However, the platform failed the load cell characterization test.The load cell module #1 will be replaced to address the issue.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 platform with serial number (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19226846
• Report Number: 3010617000-2024-00357
• Device Sequence Number: 20553647
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: MODEL 100
• Device Catalogue Number: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2009
• 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