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

Model Number	MODEL 100
Medical Device Problem Codes	No Display/Image (1183); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform (s/n (b)(4)) was received on (b)(6) 2016 at zoll (b)(4) for evaluation.The investigation results are as follows: a review of the device history record showed no related complaints that were previously reported for this device.During visual inspection a hole on the load plate cover was observed.During functional testing, when the platform was turned on, the processor pca board was found to be defective.This could cause the lcd screen to fail during power on self-check.Parts replaced: processor pca board and load plate cover in conclusion the reported event of the display screen was dark was confirmed during functional testing.The "dark screen" was caused by a defective pca board, which was replaced to resolve the issue.The reported issue of hearing "noise" was not confirmed.They were unable to detect any loose object that could have caused the rattling noise inside the device.The platform passed final functional test.
Event or Problem Description
It was reported that the autopulse platform's (s/n (b)(4)) display was not showing any information and was "dark." there was no report of patient involvement.No additional information was provided.

• 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: 5474267
• Report Number: 3010617000-2016-00124
• Device Sequence Number: 16227864
• Product Code: DRM
• UDI-Device Identifier: 00849111001175
• UDI-Public: 00849111001175
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2016

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: 8700-0740-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2016
• Initial Report FDA Received Date: 03/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1