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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint was confirmed during functional testing.It was determined that the root cause of the ua 41 error message was due to a defective temperature sensor.The faulty part identified was replaced and as expected, the platform passed all the final functional testing and ready for clinical use.Unrelated to the reported complaint, during visual inspection, damaged load plate cover was observed.This type of physical damage on the device can occur due mishandling of the platform.The load plate cover was replaced.The autopulse platform is a reusable device and was manufactured on 05 mar 2015.Historical complaints were reviewed for service information related to the reported complaint and there was (b)(4) similar complaint reported for autopulse serial number (b)(4).Ccr (b)(4) reported on (b)(4) 2017.

Event Description

As reported, the autopulse platform (sn (b)(4)) displayed ua 41 "patient temperature sensor failure" error message during shift check.User was unable to clear error log on the screen.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7661559
• MDR Text Key: 113192612
• Report Number: 3010617000-2018-00688
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• 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