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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll on 12/09/2016 for investigation.The customer's reported complaint of error message user advisory (ua) 30 error was not confirmed during functional test and archive review.However a "system error "out of service revert to manual cpr" error message was observed upon power up.The service technician replaced the processor board to remedy the fault.Review of archive data showed numerous faults "ua139" (unable to hold compressions) appeared on (b)(6) 2016.There were no ua30 (error communicating with fan controller) found in the archive file.During the visual inspection it was found out that the top cover front/bottom enclosures was cracked.The battery connector was damaged and had sticky clutch.The autopulse is a resuscitation device and was manufactured on 05/21/2010 therefore this type of damages can occur due to normal wear and tear of the device and is unrelated to the reported complaint.An additional repair and update was completed (unrelated to the reported complaint) to ensure that the autopulse platform was functional without issue.The top cover (front and bottom closures) along with the battery cable was replaced.Clutch plate deburring was also performed to fix the sticky clutch.Once the repair was completed,the autopulse passed the 15 minutes run in test with lrtf ( large resuscitation test fixture ).Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with sn (b)(4).

Event Description

It was reported that during shift check customer received an error message 30 ( error communicating with fan controller) and an audible message to perform manual cpr.Customer was unable to clear the error message.No patient involvement was 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6207676
• MDR Text Key: 63369864
• Report Number: 3010617000-2016-00957
• 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: 12/27/2016

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2010
• 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