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

Model Number MODEL 100

Device Problem Display Difficult to Read (1181)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint of 'autopulse platform system (sn (b)(4)) liquid crystal display (lcd) screen did not display any data' was confirmed during functional test.The most probable root cause is due to damage processor board.During visual inspection, there was not visual damage observed on the returned autopulse platform.Functional test was unable to be performed, the autopulse platform displayed a blank screen upon powering up the device.The processor board was replaced to correct the fault.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

It was reported that when the autopulse platform system is powered up the liquid crystal display (lcd) screen did not display any data or text.The user tried multiple times with no results.This was noted in-house, no patient involvement.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8660587
• MDR Text Key: 147238283
• Report Number: 3010617000-2019-00440
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1