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 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) displaying a "system error, out of service, revert to manual cpr" error message was confirmed during functional testing and during the review of the archive.Root cause was determined to be a faulty processor board.The platform failed the initial functional testing due to system error (latch error 136 - internal parameter corrupted) was observed upon powering up the device.A review of the autopulse's archive was performed and it shows fault 136(internal parameter corrupted), thus confirming the reported complaint.Visual inspection was performed and found missing battery partition cover, unrelated to the reported complaint.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.Due to the age of the device this platform will be scrapped.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

During shift check, the autopulse platform (sn (b)(4)) was displaying an error message " system error, out of service, revert to manual cpr".No patient was involved.

• 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: 7617431
• MDR Text Key: 111997781
• Report Number: 3010617000-2018-00638
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2004
• 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