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

Model Number	MODEL 100
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
As reported, the autopulse platform powered off during the compression.The issue persists even after the user replaced the batteries.No additional information was available.No known impact or consequence to the patient was provided.
Additional Manufacturer Narrative
The customer reported complaint for the autopulse platform powered off during the compression was not confirmed during archive review and during functional testing.There were no device deficiencies found during the evaluation of the platform which could have caused or contributed to the reported complaint.During the functional testing, 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.There was no device malfunction observed.The load cell characterization test confirmed both load cell modules are functioning within the specification.Unrelated to the reported complaint, a damaged load plate cover on the returned platform was observed during visual inspection.The load plate cover needs a replacement to address the issue.This type of physical damage found during visual inspection is characteristic of user mishandling.In addition, unrelated to the reported complaint, noted very stiff driveshaft rotation of the drive train motor.The root cause of the issue was caused by a mechanical malfunction of the drive train motor.The drive train motor was replaced to remedy the issue.The autopulse platform is a reusable device and was manufactured in april 2011 and is almost 9 years old, well beyond the expected service life of 5 years.Therefore, this type of issue found during the evaluation is characteristic of normal wear and tear for the life of the device.Per archive, the last time the autopulse platform was used on (b)(6) 2019.Per customer, the problem occurred date was on (b)(6) 2019 and there was no evidence on the archive data showing that the platform was used on the customer reported event date.Probably, the customer reported on a wrong platform or wrong event date.Following the service and repair, the platform was further tested with large resuscitation testing fixture, (lrtf) equivalent to the 250-pound patient and passed all functional testing criteria and met all required specifications.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9584455
• Report Number: 3010617000-2020-00016
• Device Sequence Number: 13589856
• Product Code: DRM
• UDI-Device Identifier: 00849111000154
• UDI-Public: 00849111000154
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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: 8700-0700-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1