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

Model Number MODEL 100

Device Problems Device Operates Differently Than Expected (2913); Failure of Device to Self-Test (2937)

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

Event Date 01/19/2015

Event Type  malfunction  

Event Description

It was reported that during patient care, the autopulse platform was powered on and displayed the "initializing" message; however, it did not proceed pass its self-tests and did not start compressions.Customer used multiple fully charged autopulse li-ion batteries but the platform did not provide any compressions.The crew reverted to manual cpr (exact length of time was not provided).No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/30/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform was performed and found no damages to the platform.The platform was unable to undergo initial functional testing as it exhibited a user advisory (ua) 16 (timeout moving to take-up position) upon power on.A review of the platform's archive data was performed and found that multiple ua 2 (compression tracking error), ua 7 (discrepancy between load 1 and load 2 too large), ua 12 (lifeband not present) and ua 16 (timeout moving to take-up position) messages occurred on the reported event date of (b)(6) 2015.Per the autopulse technical service guide (p/n 11377-006), ua 2 is exhibited when the platform detects a change in lifeband tension.This advisory happens when either the patient or the lifeband is out of position, or if the lifeband is opened during active operation.Per the autopulse technical service guide (p/n 11377-006), ua 7 is exhibited when the platform detects that the patient is not properly centered.Per the autopulse® maintenance guide (p/n 11653-001), ua12 occurs when the autopulse detects that the lifeband is not properly installed.The autopulse is designed to exhibit user advisories to prevent patient injury.Based on the investigation, no parts needed to be replaced to remedy the customer's reported complaint of the platform not proceeding past the "initialization" stage; however, the drivetrain motor brake was cleaned to remedy the customer's reported complaint.The platform then underwent and passed all final functional testing.In summary, the customer's reported complaint of the platform not proceeding past the "initialization" stage was confirmed through initial functional testing, and also visually, once the platform was opened up.The root cause of the reported complaint was determined to have been due to the drivetrain motor brake seizing and not opening.The drivetrain motor brake was cleaned, remedying the customer's reported complaint.

• 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: 4517428
• MDR Text Key: 5487707
• Report Number: 3010617000-2015-00094
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• 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: 01/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2009
• 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
• Treatment: MANUAL CPR