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 No Patient Involvement (2645)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

During preventive maintenance, the autopulse platform ((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 platform failed the initial functional testing due to system error (latch error 136 - internal parameter corrupted) was observed upon powering up the device.Visual inspection was performed and found missing battery partition cover and damage motor cover.Following the replacement of defective parts, the device was further tested and passed all testing criteria with no issues or faults observed.The autopulse platform is a reusable device as well as a serviceable device and was manufactured in 2004.Therefore, this type of physical damages found during visual inspection are characteristics of normal wear and tear for the life of the device.The platform has exceeded its expected service life of 5 years.

Event Description

The autopulse platform ((b)(4)) was returned for preventive maintenance.As part of routine service, the device was tested and during initial power up, displayed system error, out of service, revert to manual cpr" error message.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7494768
• MDR Text Key: 107608338
• Report Number: 3010617000-2018-00526
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2004
• 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