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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint for the autopulse platform displayed user advisory (ua) 17 (max motor on time exceeded during active operation) was confirmed during archive review and during functional testing.The root cause is due to a defective drivetrain motor likely due to aging.The autopulse platform is a reusable device and was manufactured in january 2008 and is 12 years old, well beyond the expected service life of 5 years.The drive train motor was replaced to remedy the fault.Visual inspection of the returned platform was performed and found no physical damage.The platform passed the initial functional testing without any fault or error, however, during the run-in test, the platform stopped compressions due to user advisory (ua) 17 error message when the platform was tested with large resuscitation testing fixture, (lrtf) equivalent to the 250-pound patient.Thus confirming the customer complaint.A review of the archive data indicated user advisory (ua) 17 (max motor on time exceeded during active operation) error occurred on the reported event date.Upon customer approval, the defective component will be replaced and the device will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for the autopulse sn 21606.
Event or Problem Description
During the shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 17 (motor on for too long during active operation) error message.No patient involvement.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9800685
• Report Number: 3010617000-2020-00238
• Device Sequence Number: 19525721
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 03/06/2020

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1