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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem Not Applicable (3189)

Event Date 02/23/2018

Event Type  malfunction  

Manufacturer Narrative

During preventive maintenance, the autopulse platform (sn (b)(4)) displayed an error message system error, out of service, revert to manual cpr".The defective processor board was replaced to remedy the fault.The autopulse platform was manufactured in 2006 and is 12 years old, well beyond the expected service life of five years.The platform failed the initial functional testing due to the error message "system error, out of service, revert to manual cpr" displayed upon powering on the device.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform sn (b)(4).

Event Description

The autopulse platform (sn (b)(4)) was returned for preventive maintenance and as part of routine service during testing, the platform was examined and displayed a system error, out of service, revert to manual cpr message on the user control panel during initial power up.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7367838
• MDR Text Key: 103729070
• Report Number: 3010617000-2018-00400
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 03/23/2018

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2006
• 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