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 Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) intermittently display user advisory (ua) 41 (patient temperature sensor failure) error message was confirmed during functional testing and archive data review.During functional testing, the platform displayed ua 41 error message on the user control panel upon power up.However the ua 41 was cleared during evaluation.The archive data was reviewed and contained multiple user advisory (ua) 41 (patient temperature sensor failure) error messages.As a precautionary measure to prevent the reoccurrence of the ua 41 error message, the temperature sensor cabling and processor board were replaced.The storage and shift check conditions are not known; however, factors such as ambient storage condition (e.G., fire truck in sun) or soft surface that may block air vents are known to cause ua 41 error messages in rare cases.The autopulse platform is a reusable device and was manufactured on 21 feb 2013.It has exceeded its expected service life of 5 years.The platform has not seen regular preventive maintenance.As part of the routine service during testing, the device was examined and observed a defective shaft lock pin, load cell, and encoder gearbox.Additionally a sticky clutch plate.These observations are not related to the reported event.After replacement of the defective parts and clutch plated deburring, the platform was functionally tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse serial number (b)(4).

Event Description

During shift check, the autopulse platform (sn (b)(4)) intermittently displays user advisory (ua) 41.Additionally, customer requested preventive maintenance for the platform.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: 7579985
• MDR Text Key: 110459426
• Report Number: 3010617000-2018-00616
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• 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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• 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