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

Model Number	MODEL 100
Medical Device Problem Codes	Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2019, during preventive maintenance, the lcd screen back-light of the autopulse platform (sn (b)(4)) was flickering and the screen was difficult to read.The root cause for the observed lcd problem was due to the defective lcd display as a result of aging of the device.The autopulse platform was manufactured in 2012 and is 7 years old, past the expected service life of 5 years.The lcd display was replaced to remedy the problem.Upon visual inspection, noticed flickering lcd screen.No physical damage was observed.During functional testing, the autopulse platform performed compressions without any fault or error.The archive data could not be downloaded due to the defective processor pca (printed circuit assembly).The processor pca was replaced to remedy the problem.Following service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning 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 previous history of complaint reported for autopulse platform with sn (b)(4).
Event or Problem Description
On (b)(6) 2019, during preventive maintenance, the lcd screen back-light of the autopulse platform (sn (b)(4)) was flickering and the screen was difficult to read.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9363292
• Report Number: 3010617000-2019-01064
• Device Sequence Number: 16666659
• Product Code: DRM
• UDI-Device Identifier: 00849111001274
• UDI-Public: 00849111001274
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: 8700-0740-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1