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

Model Number MODEL 100

Device Problems Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 07/25/2014

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2014, the autopulse platform was used outdoors on a patient.The platform ran normally using 1 and a half batteries.Customer stated that there was blood and mud all over the platform so the hospital staff rinsed it all down.Upon shift check the next morning ((b)(6)2014), the crew found that the platform displayed a user advisory (ua) 28 (loss of clutch connectivity) message and then a "system error, out of service" message after a few compressions.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 08/12/2014 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 the encoder cover and motor cover to both be damaged.Initial functional testing could not be performed as the platform exhibited a "system error, out of service" message (error code 139 - unable to hold compression position) upon power up.The error code 139 was cleared and the ua 28 was not replicated during testing.A review of the platform's archive was performed and the customer's reported complaint of user advisory (ua) 28 (loss of clutch connectivity) and "system error, out of service" (error code 139) messages were both noted.The following ua's were also noted on the reported event date of 07/25/2014: ua 17 (max motor on time exceeded during active operation), ua 7 (discrepancy between load 1 and load 2 too large), warning 1 (low battery warning), and ua 4 (battery charge state too low), fault 8 (motor controller fault detected), ua 18 (max take-up revolutions exceeded) and ua 2 (compression tracking error).Per the autopulse® maintenance guide (p/n 11653-001), ua 17 typically occurs when the lifeband® is twisted, or the battery voltage is low.At the time the ua 17 occurred, li-ion battery s/n (b)(4) was in use on the platform and had the proper amount of voltage, thus ruling out use of a battery with low voltage as a root cause.Based on the evaluation of the archive, the most probable root cause of the ua 17 was a twisted lifeband®.Per the autopulse® maintenance guide (p/n 11653-001), ua 7 typically occurs when the patient is out of position and/or not properly centered.As there were no problems with the platform's load cells, the most probable cause of the ua 7 was alignment of the object that the customer had on the platform.Warning 1 occurs because the platform is notifying the user that the battery's charge is getting low and will need to be replaced shortly.This warning was exhibited by the platform after li-ion battery with s/n (b)(4) had been in use for over 27 minutes.The expected run-time for a fully charged li-ion battery is 30 minutes, which this battery did meet.Per the autopulse® maintenance guide (p/n 11653-001), ua 4 occurs when the battery's charge becomes too low.Again, the li-ion battery with s/n (b)(4) ran as expected, and the platform exhibited ua 4 to prevent interruption in therapy.The root cause for the noted fault 8's could not be determined.The fault was not repeated during functional testing at zoll.Per the autopulse® maintenance guide (p/n 11653-001), ua 18 occurs when the autopulse® has detected that either the patient's chest size is too small or that there is no patient on the platform.The root cause was determined to be no patient on the platform per review of the archive.Per the autopulse® maintenance guide (p/n 11653-001), ua 2 occurs when the autopulse® has detected a change in lifeband® tension.As there were no issues identified during functional testing associated with ua 2, the probable root cause of the exhibited ua 2 was determined to be a change in the lifeband® tension.The autopulse® is designed to exhibit ua 2 to prevent patient harm due to changes in lifeband® tension.A review of the platform's archive was performed to assess the customer's battery management practices.Review of the archive shows that the customer was properly maintaining their batteries.No parts were replaced to remedy the customer's reported ua 28 or "system error, out of service" messages (error code 139).The error code 139 was cleared and the ua 28 was not replicated during testing.Additional parts replaced not related to the reported complaint to ensure that the autopulse platform is functioning without issue: the motor cover gasket and encoder cover gasket were both replaced.The platform underwent and met all final testing criteria.The customer's reported complaint of the platform exhibiting ua 28 and "system error, out of service" messages (error code 139) was confirmed through review of the platform's archive data.The error code 139 was also confirmed upon initial functional testing.The root cause of both the ua 28 and "system error, out of service" messages could not be determined.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4021175
• MDR Text Key: 18571933
• Report Number: 3010617000-2014-00419
• 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: 07/25/2014

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: 08/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 08/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2006
• 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