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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported a complaint of the burnt smell during the use of the autopulse platform (sn (b)(4) could not be confirmed during the platform investigation.The secondary complaint of the platform stopped compressions was confirmed during the archive data review and the functional testing.The cause for the reported complaint, based on the archive data review, was due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message, as a result of a defective load cell module.The cracked bottom enclosure and defective load cell module were likely attributed to mishandling, such as a drop.Upon visual inspection, unrelated to the reported complaint, noticed a cracked bottom enclosure.The probable root cause for the observed physical damage could be due to user mishandling such as a drop.The bottom enclosure needs to be replaced to address the observed physical damage.In addition, unrelated to the reported complaint, the encoder driveshaft of the platform does not rotate smoothly and exhibits binding and resistance due to a sticky clutch plate.This type of driveshaft issue is characteristic of the wear and tear of the platform.The impact of a sticky clutch was not severe enough to make the platform non-functional.Deburring of the clutch plate needs to be performed to remedy the encoder driveshaft issue.The autopulse platform was manufactured in march 2017 and is 5 years old, and reached the expected service life of 5 years.The autopulse platform passed the initial functional testing without any fault or error.During further testing, the platform failed the load cell characterization test as the load cell module exceeded normal parameters.The defective load cell module needs to be replaced to remedy the (ua) 07 error.A review of the archive data showed multiple (ua) 07 error messages to have occurred around the customer's reported event date, thus confirming the reported complaint.Waiting for customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform with serial number (b)(4).
Event or Problem Description
During the patient use, the user noticed a burnt smell from the autopulse platform (sn (b)(4) and the platform stopped compressions.There were no error messages displayed on the autopulse platform.No consequences or impact to the patient.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 14261580
• Report Number: 3010617000-2022-00432
• Device Sequence Number: 4439056
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/29/2022

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 05/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2017
• 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