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

Model Number MODEL 100

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

Patient Problems Cardiac Arrest (1762); Death (1802); Loss of consciousness (2418); Respiratory Failure (2484)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

A call came in for an unresponsive, (b)(6) male patient who was not breathing.Patient weighed (b)(6).The arrest occurred at the patient's workplace and was witnessed by his coworkers.Patient was down for about 4 minutes prior to ems arrival.It is unknown if bystander cpr was performed.Upon arrival, ems crew initiated manual cpr (exact length of time was not provided).The crew applied defibrillation pads and placed the autopulse platform under the patient.The platform was deployed without any issues.It performed 3-4 compressions, then stopped and displayed a fault 17 (max motor on time exceeded during active operation) message.The crew attempted to restart the platform by pulling the lifeband completely up and pressing "restart".However, another fault 17 message displayed.Manual cpr was performed in between attempts to restart the platform.Patient did not require extrication and was not being moved at the time of the faults.Customer indicated that head immobilizers and shoulder restraints were not used.He also stated that the lifeband was not twisted.The crew immediately reverted to manual cpr for the duration of the call to the hospital, which was about 14 minutes.During transport, the patient was also being bagged and suctioned.The patient was transported to the hospital in 3 minutes.Manual cpr was continued until arrival at the emergency room (exact length of time was not provided).Once in the er, the first autopulse platform was discontinued and a second autopulse platform was deployed.There were no issues with deployment of this second platform.The platform performed 3-4 compressions, then stopped and displayed a user advisory (ua) 2 (compression tracking error) message.The crew attempted to restart the platform; however, a fault 17 message displayed.Use of the autopulse was discontinued.Customer indicated that the patient was not being moved at the time of the user advisory and fault messages.He also stated that the lifeband was not twisted.The crew reverted to manual cpr until the patient was pronounced dead by the ed physician (exact length of time was not provided).Return of spontaneous circulation (rosc) was never achieved.Patient expired on the same day.Customer could not provide the cause of death and could not provide any patient medical history.In addition, customer could not say if the patient's death was attributed to the use of the autopulse platforms.He indicated that the patient was already in cardiac arrest and it is unknown if the delay time might have changed the chances of survival.

Manufacturer Narrative

Customer also indicated that they were using li-ion batteries at the time of the call.The battery status icon on the platform's display indicated that the batteries were fully charged.Customer's daily shift checks include taking the battery out of the autopulse platform and placing it into the charger.Then taking the battery from the charger and placing it into the platform.Please see the following related mfr report: 3010617000-2014-00539 for autopulse platform s/n (b)(4).The autopulse platform in complaint was returned to zoll on 10/10/2014 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and no damages were observed.The reported issue of the platform stopping compressions and displaying a user advisory 17 (max motor on time exceeded during active operation) and a user advisory 2 (compression tracking error) could not be duplicated during functional evaluation.The platform was run with a test mannequin and a large resuscitation test fixture (equivalent to a 250 lb.Patient), using known good test batteries and no issues were observed during compressions.Li-ion battery (s/n (b)(4)), which was used with the platform on the reported event date of (b)(6) 2014 was also returned.The platform was functionally tested a second time with this battery and the platform performed as intended, with no user advisories occurring.Load cell characterization was also performed and confirmed that both load cells were functioning within specification.A review of the archive showed that multiple user advisory 17 and user advisory 2 codes occurred on the event date, thus confirming the reported complaint.Possible mechanical issues which could cause ua 17 code are a faulty drivetrain motor as well as the brake gap being out of specification.Inspection of the device ruled both of these causes out and confirmed both were within specification.There were also no issues observed in the archive with the battery (li-ion - s/n (b)(4)) used at the time the ua 17 codes occurred.The battery had sufficient remaining capacity of 1266 mah while being used at this time.A definitive cause for the ua 2 codes could not be determined.The ua 2 codes can occur as a result of the load cells not functioning properly or due to patient movement causing a load imbalance of greater than 20lbs between load cells 1 and 2.However, both load cells were verified as operating within specification during load cell characterization.Additionally, information provided by the customer stated that the patient was not being moved at the time the ua codes were displayed.In addition to the reported ua 17 and ua 2, the archive also showed that multiple user advisory 7 (discrepancy between load 1 and load 2 too large) and user advisory 18 (max take up revolutions exceeded) codes, occurred on (b)(6) 2014.A definitive cause for these user advisories could not be determined.The ua 7 code can occur as a result of the load cells not functioning properly or due to patient movement causing a load imbalance of greater than 20lbs between load cells 1 and 2.However, both load cells were verified as operating within specification during load cell characterization.Additionally, information provided by the customer stated that the patient was not being moved at the time the ua codes were displayed.A cause for the ua 18 also could not be determined based on the investigation.There were no mechanical issues or any data in the archive that indicate the device caused or contributed to the ua 18.A review was conducted and there were no issues with battery management observed.Based on the investigation, there were no parts identified for replacement to remedy the reported complaint.In summary, the reported complaint of the platform displaying ua 17 and ua 2 codes was confirmed through archive review.A cause could not be determined.Possible mechanical issues which could cause the ua 17 code are a faulty drivetrain motor as well as the brake gap being out of specification.The ua 2 codes can occur as a result of the load cells not functioning properly or due to patient movement causing a load imbalance of greater than 20lbs between load cells 1 and 2.Evaluation of the platform did not identify any mechanical issues which could have caused or contributed to these ua codes.There was also no data in the archive that indicates the platform could have caused or contributed to the observed codes.Li-ion battery (s/n (b)(4)), which was used with the platform on the reported event date of (b)(6) 2014 was also returned.The platform was functionally tested with this battery and the platform performed as intended, with no user advisories occurring.Multiple ua 7 and 18 codes were also seen in the archive occurring on the reported event date.A definitive cause for these advisories could not be determined.It should be noted that there were no mechanical issues with the platform or any data in the archive that indicate the device caused or contributed to either the ua 7 or ua 18 codes.Following service, the device passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4201352
• MDR Text Key: 5038723
• Report Number: 3010617000-2014-00540
• 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: 10/01/2014

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: 10/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 10/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2009
• 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
• Patient Age: 59 YR
• Patient Weight: 91