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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem Cardiac Arrest (1762)

Event Date 02/20/2015

Event Type  malfunction  

Event Description

It was reported that during use on a cardiac arrest, male patient weighing less than 300 lbs, the autopulse platform performed 5 compressions, then stopped and displayed a "realign patient" message.Customer stated that it may have been a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) or ua 17 (max motor on time exceeded during active operation) message.The crew realigned the patient 3 or 4 times with the same results.The platform performed a couple of compressions and then stopped again.Manual cpr was performed in between attempts to restart compressions with the platform.The crew discontinued use of the platform and reverted back to manual cpr (exact length of time was not provided).It is unknown if manual cpr was performed prior to use of the autopulse.No adverse patient sequelae was reported.It is unknown if patient achieved return of spontaneous circulation (rosc) or what the patient's condition was at the time of delivery to the hospital.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 04/07/2015 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 no physical damages were noted.A review of the platform's archive data was performed and found no anomalies or errors on the reported event date of (b)(6) 2015.However, multiple user advisory (ua) 2 (compression tracking error), ua 17 (max motor on time exceeded during active operation), ua 18 (max take-up revolutions exceeded) and ua 45 (not at "home" position after power-on/restart) messages were noted on (b)(6) 2015.Per the autopulse® maintenance guide (p/n 11653-001), ua 2 is exhibited when the platform detects a change in lifeband tension.This advisory can happen when the patient or the lifeband is out of position, or if the lifeband is opened during active operation.Per the autopulse® maintenance guide (p/n 11653-001), ua 17 may typically occur if the lifeband® is twisted or if the battery voltage is low.It should be noted that review of the platform's archive showed that a fully charged (high remaining capacity) autopulse li-ion battery (serial number (sn) (b)(4)) was used at the time of the ua 17 messages.Per the autopulse® maintenance guide (p/n 11653-001), ua18 is exhibited when the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.It should be noted that review of the platform's archive showed that there were no load changes on the platform at the time that the ua 18 was exhibited.Per the autopulse user guide, 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 ua 45 will occur.This ua will persist until the driveshaft is returned to its home position by pulling up on the lifeband until the chest bands are fully extended.The returned platform underwent initial functional testing using a 95% patient test fixture with no faults or errors exhibited.Load cell characterization testing was performed, which confirmed that both load cells were functioning as intended.In addition, a brake gap inspection was performed and verified that the brake gap was within the specification of 0.008" ±0.001".There were no mechanical issues identified with the returned platform that may have caused or contributed to the ua's found during the archive review.Based on the investigation, no parts were identified for replacement.The platform underwent and passed all final functional testing.In summary, the customer's reported complaint was confirmed through review of the platform's archive data.Review of the archive found multiple ua 2, ua 17, ua 18 and ua 45 messages on (b)(6) 2015, rather than on the reported event date of (b)(6) 2015.Based on evaluation of the returned platform, there were no mechanical issues identified with the returned platform that may have caused or contributed to these ua's.A possible root cause of the ua 2 messages was determined to be patient movement.The root cause of the ua 17 messages could not be determined because the battery was not returned for investigation and there were no issues noted during brake gap inspection that may have caused or contributed to the ua 17.In addition, a root cause of the ua 18 messages could not be determined.The root cause of the ua 45 messages may have been due to the lifeband not being fully extended prior to turning the device on.

• 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: 4691254
• MDR Text Key: 19346701
• Report Number: 3010617000-2015-00227
• 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: Paramedic
• Type of Report: Initial,Followup
• Report Date: 03/20/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 04/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• 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