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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn (b)(6)) displayed fault 41 (patient temperature sensor failure) was not confirmed during the functional test but was confirmed during the archive data review.No device malfunction was observed during the functional testing and the autopulse platform performed as intended.Nevertheless, the temperature sensor was replaced as a preventive precautionary measure, as the sensor may have had some intermittent technical problems that could not be directly identified during the functional testing.Upon visual inspection, observed a cracked front enclosure, which is unrelated to the reported complaint.The observed physical damage is likely attributed to mishandling such as a drop.The front enclosure needs to be replaced to address the physical damage.Also, unrelated to the reported complaint, a hole on the load plate cover was observed that affected the watertight seal, likely attributed to user mishandling.The load plate cover needs to be replaced to address the observed physical damage.The autopulse platform was manufactured in 2015 and it is more than 8 years old, past its expected serviceable life of 5 years.The archive data review indicated fault 41, thus confirming the reported complaint.The autopulse platform passed the initial functional test without any fault or error and the reported complaint could not be reproduced.The autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any fault or error.Nevertheless, the temperature sensor needs to be replaced as a preventive precautionary measure.Awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with sn 41430.
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(6)) displays a fault 41 (patient temperature sensor failure) message.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19525271
• Report Number: 3010617000-2024-00460
• Device Sequence Number: 15328776
• 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): 06/12/2024

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: 06/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2015
• 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