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

Model Number MODEL 100

Device Problems Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem Cardiac Arrest (1762)

Event Date 09/29/2014

Event Type  malfunction  

Event Description

It was reported that during use on a (b)(6) female patient in cardiac arrest on (b)(6) 2014, the autopulse platform stopped performing compressions.The crew reported that the platform did not display any user advisory or error messages.Manual cpr was initiated while the crew restarted the platform (exact length of time was not provided).After a few seconds of compressions, the autopulse stopped again.The crew stated that there was no indication as to why the platform stopped.Use of the autopulse platform was then discontinued and 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

Please note that the autopulse platform in complaint was returned to zoll on 11/21/2014 for a previous report under mfr.Report #3010617000-2014-00641.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 the lcd backlight to not be functioning.The returned platform underwent and failed initial functional testing as the lifeband was unable to lock into the platform and fell out of the channel.The drivetrain was also found to be defective.A review of the platform's archive data was performed and found that user advisory (ua) 45 (not at "home" position after power-on/restart) and ua18 (max take-up revolutions exceeded) occurred on the reported event date of (b)(6) 2014.The drivetrain motor and clutch plate were replaced to remedy the ua 45 & ua 18.Additionally, the lifeband channel and processor pca board were replaced.The platform underwent and passed all final functional testing.In summary, the customer's reported complaint of the platform stopping compressions during patient treatment was confirmed through review of the platform's archive data.The platform exhibited both ua 45 and ua 18 on the reported event date of (b)(6) 2014.The root cause of both the ua 18 and ua 45 was determined to be a defective drivetrain and clutch plate, which were both replaced.The autopulse® was designed to exhibit both ua 18 and ua 45 to prevent patient harm.

Manufacturer Narrative

Additional manufacturer narrative on follow-up report #1 indicated the following: "a review of the platform's archive data was performed and found that user advisory (ua) 45 (not at "home" position after power-on/restart) and ua18 (max take-up revolutions exceeded) occurred on the reported event date of (b)(6) 2014." this sentence is incorrect and should read as follows: "a review of the platform's archive data was performed and found that user advisory (ua) 45 (not at "home" position after power-on/restart) occurred on the reported event date of (b)(6) 2014." upon further review of the platform's archive, it was determined that ua 18 did not occur on the reported event date.Additional manufacturer narrative on follow-up report #1 indicated the following: "the drivetrain motor and clutch plate were replaced to remedy the ua 45 and ua 18." this statement is incorrect.Please see below for further investigation results.Additional investigation results for the returned platform: visual inspection of the platform identified that the liquid crystal display (lcd) backlight was not functioning.The lcd backlight illuminates the screen on the autopulse platform to facilitate reading of any messages displayed by the autopulse platform.The lcd backlight has no impact on how autopulse performs compressions.Investigation of the lcd backlight issue identified the processor printed circuit assembly (pca) board needed to be replaced in order to resolve the blank display issue.The processor pca includes circuitry that controls the backlight on the lcd.When the processor pca is functioning normally, powering up of autopulse activates the backlight on the lcd.Failure of the processor pca caused the backlight to turn off and remain off.The root cause of the customer's reported complaint was the failure of the pca which caused the lcd backlight to not illuminate the display.Unrelated to the customer's complaint on (b)(6) 2014, visual inspection of the autopulse platform identified that the lifeband would loosely lock into the autopulse platform.The loose lifeband issue was communicated by the customer to zoll representative who was visiting the customer site and was not related to or did not contribute to the blank display issue.This lifeband fit did not affect the use of the autopulse.On the date of the reported event ((b)(6) 2014), the autopulse exhibited user advisory 45 (not at "home" position after power-on restart).User advisory 45 is a recoverable issue for the autopulse platform.Per the autopulse user guide instructions, "the autopulse driveshaft has a "home" position that is a point of reference for autopulse operation.If the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45), pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart." user advisory 45 provides an alert to the user to take an action for proper use.This is by design and does not constitute a device failure or malfunction.The product labeling provides instructions on how to clear the ua 45.Based on the following functional evaluation, there were no issues identified with the platform.The platform ran with a large resuscitation test fixture (equivalent to a 95 percentile patient) without faults or errors.The device performed as intended during full functional evaluation.The processor pca board was replaced to resolve the blank display issue.In addition, the channel was replaced to improve the lifeband fit.Channel is the portion of the autopulse to which the lifeband is attached and secured.Although the channel was replaced as part of the service of the autopulse platform, the channel did not contribute to the blank display issue.This issue did not affect device function.Please also note that the drive train motor, clutch plate and power distribution board (pdb) were functional but exhibited unexpectedly high wear and tear and were replaced.The additional serviceable items were not related to and did not contribute to the customer's reported complaint.The customer reported that the autopulse performed compression, stopped, but the user could not see any messages on the lcd display.The archive data shows that there were no compressions performed.However, the lcd backlight was not functioning.Replacing the processor pca resolved the display problem.The blank display prevented the customer from being aware of the user advisory 45 message that was prompted.Since the user could not read the lcd, they did not take the required actions to clear the ua 45.This root cause was identified and resolved.Upon replacement of all parts, the autopulse platform was re-evaluated through full functional testing and passed all testing criteria without issue.

• 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: 4347676
• MDR Text Key: 20785138
• Report Number: 3010617000-2014-00665
• 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: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2014

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: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 12/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/28/2015; 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2011
• 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
• Patient Age: 54 YR