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 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform ((b)(4)) displayed 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.As a precautionary measure to prevent the reoccurrence of the ua 41 error message, the temperature sensor cabling was 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.No physical damage was observed during visual inspection.Review of the archive data show (ua) 41 error messages occurred on the reported event date.As part of routine service, the platform was tested with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient and failed with user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message, unrelated to the reported complaint.Platform failed load cell characterization test and load cell conversion was performed to address the issue.The autopulse platform is a reusable device and was manufactured in april 2006 and is 12 years old.It has exceeded its expected service life of 5 years.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse platform with serial number (b)(4).(b)(4), reported on (b)(6) 2013.Defective temperature sensor was replaced.

Event Description

As reported, the autopulse platform ((b)(4)) was displaying an error message user advisory (ua) 41 (patient temperature failure) when powered on.No further information was provided.No known patient consequences reported.

• 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: 7597984
• MDR Text Key: 111006432
• Report Number: 3010617000-2018-00626
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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: 05/24/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2006
• 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