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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problems Cardiac Arrest (1762); Death (1802); Respiratory Distress (2045)

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: 3010617000-2014-00540 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 to the manufacturer for analysis.Visual inspection was performed and the following was observed: the top cover was cracked and the battery bay compartment's bosses were damaged.From the condition of the returned unit, the cause of the damages appear to be wear and tear.The reported issue of the platform stopping compressions and displaying a user advisory 17 (max motor on time exceeded during active operation) code 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 batteries (s/ns (b)(4)), which were used with the platform on the reported event date of (b)(6) 2014 were also returned.The platform was functionally tested a second time with both of these batteries and the platform performed as intended, with no user advisories occurring.Load cell characterization was also performed and confirmed that load cell 2 was under-reporting.It should be noted that the reported ua 17 is unrelated to load cell function.The archive showed two user advisory 17 codes occurring on the event date.Possible mechanical issues which could cause this code are 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 1283 while being used at this time.The archive also showed multiple user advisory 7 (discrepancy between load 1 and load 2 too large) codes occurred on (b)(6) 2014.The observed ua 7 codes are attributed to the previously noted load cell 2 module under-reporting.A review was conducted and there were no issues with battery management observed.Based on the investigation, the part(s) identified for replacement are the top cover, battery compartment bosses and load cell module.In summary, the reported ua 17 code was confirmed in the archive; however a cause could not be determined.There was no data in the archive or any mechanical issues observed with the platform that could have caused or contributed to the ua 17 codes.Unrelated to the reported complaint, multiple ua 7 codes were also seen in the archive occurring on the reported event date.The cause of the ua 7 codes was confirmed to be load cell module 2 under-reporting during load cell characterization.Li-ion batteries (s/ns (b)(4)), which were used with the platform on the reported event date of (b)(6) 2014 were also returned.The platform was functionally tested with both of these batteries and the platform performed as intended, with no user advisories occurring.Following service, including replacement of the damaged parts and load cell module 2, 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: 4201227
• MDR Text Key: 5153062
• Report Number: 3010617000-2014-00539
• 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

• Date FDA Received: 10/27/2014
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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