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	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During preventative maintenance (pm), the autopulse platform (sn (b)(6) failed functional testing with user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).A load cell characterization test was performed and revealed that load cell #2 was exceeding normal parameters, triggering the (ua) 07 advisory message.The damaged front enclosure and load cell failure were likely attributed to mishandling such as a drop, or the age of the device.The autopulse platform was manufactured in october 2015 and is over 8 years old, well beyond its expected service life of 5 years.The malfunctioning load cell was replaced to remedy the (ua) 07 advisory message.Upon visual inspection, noticed a cracked front enclosure.The probable root cause for the observed physical damage could be due to user mishandling such as a drop.The front enclosure was replaced to address the observed physical damage.As part of routine service during testing, unrelated to the noted ua07 advisory message, the platform was examined, and the encoder drive shaft does not rotate smoothly and exhibits binding and resistance due to a sticky clutch plate.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any fault or error.A load cell characterization test was performed and confirmed that both cell modules function within the specification.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 was no similar complaint reported for the autopulse platform with sn (b)(6).
Event or Problem Description
During preventative maintenance (pm) performed at zoll on june 3, 2024, the autopulse platform (sn (b)(6) failed functional testing with user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).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: 19590351
• Report Number: 3010617000-2024-00506
• Device Sequence Number: 3354269
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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: 05/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2015
• 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