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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Bruise/Contusion (1754); Cardiac Arrest (1762); Death (1802); Ventricular Fibrillation (2130)

Event Date 08/08/2014

Event Type  Injury  

Event Description

The ambulance service received a call on (b)(6) 2014 regarding an unresponsive (b)(6) year old male inmate in cardiac arrest.The inmate was in isolation for 2 weeks.He was checked on 30 minutes prior to being found unresponsive.Responders arrived on scene within 8 minutes of the call.Manual cpr was in progress by the sheriff employees.(exact length of time was not provided) upon ems arrival, an aed was used to shock the inmate 3 times.Ems crew started an iv, a cardiac monitor along with a combitube.The cardiac monitor indicated that the inmate was in ventricular fibrillation (v.Fib).Ems crew administered 1:10,000 mg of epinephrine.The autopulse platform was deployed within 3-4 minutes of ems arrival; however, the platform displayed a "check patient alignment" message.The inmate was shocked again 4 times and given 3 additional rounds of epinephrine.He remained in ventricular fibrillation and was taken to the ambulance on a stretcher.The chief stated that the message may have occurred because the inmate was being moved on a stretcher to the ambulance.During transport to the hospital, the crew attempted to start another iv but was unsuccessful.2 additional rounds of epinephrine were administered.The platform was not in use for a long time (exact time was not provided) because of the constant "check patient alignment" messages.The crew discontinued use of the autopulse and reverted to manual cpr for the duration of transport, which was about 7 minutes.The hospital was 4 miles away.The inmate was still in v.Fib.Upon arrival at the hospital.Ems crew assisted er staff as needed.However, no details were provided.The autopulse was not used at the hospital.Return of spontaneous circulation (rosc) was never achieved.While performing an autopsy, the medical examiner found unexplained bruising on the inmate.The initial findings of the autopsy revealed that the inmate had an enlarged heart.The chief indicated that there were no observed marks on the inmate at the hospital; however, they were not checking for any marks.The inmate's past medical history included dementia.He had no known medical allergies.The chief does not attribute the inmate's death to the use of the autopulse.

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 10/07/2014 for investigation.Investigation results as follows: the complaint was reported for the platform repeatedly displaying a "check patient alignment" message.In addition, the customer reported that during the autopsy of the treated patient, bruising was noted on the patient's left side and back, below the scapula.Visual inspection was performed and the following damage was observed: the user interface membrane was loose.From the condition of the unit, the damage appears to have been due to wear and tear.The platform ran with a test mannequin and a large resuscitation test fixture (equivalent to a 250 lb.Patient) with no issues encountered.Load cell characterization was also performed and both load cells were found to be reporting within specification.During testing, the operating parameters were measured to be the following: device compression depth was 1.72 inches peak, and 1.68 inches at steady state.The device duty cycle was 50% with a 79.89 compression cycle per minute averaged over three minutes.All parameters for the returned platform were found to meet manufacturer's specifications.A review of the platform's archive does not show any user advisory (ua) codes occurring on the reported event date of (b)(6) 2014.However, the following ua codes were observed on (b)(6) 2014: ua 7 (discrepancy between load 1 and load 2 too large), ua 2 (compression tracking error), ua 17 (max motor on time exceeded during active operation) and ua 12 (lifeband not present).The reported issue of the platform displaying a "check patient alignment" message was confirmed based on archive review indicating ua 7 and ua 2 codes, which are consistent with the platform displaying this message.Ua 7 codes are designed to be displayed in the event that there is too large of a measured load discrepancy between load plate 1 and load plate 2 of the platform.Possible causes include load cells not functioning properly as well as patient movement on the platform during compressions.Any issues with the load cells not functioning properly has been ruled out through load cell characterization testing of the returned platform.Based on evaluation results, which show both load cells reporting within specification, the cause of the ua 7 codes has been determined to be patient movement on the platform during compressions.This is further confirmed by information provided by the customer stating that the "check patient alignment" message may have occurred as a result of the patient being moved on a stretcher to the ambulance while compressions were being performed.The observed ua 2 codes are designed to be displayed when the patient is misaligned on the platform with not enough weight applied to the load plate during the compression.Ua 2 codes can be caused by load cell connections not functioning properly as well as misalignment of the patient on the platform.Since evaluation of the device indicated that load cell function was within specification, the cause of the ua 2 codes has been determined to be patient movement on the platform during compressions.The platform is designed to display a ua 12 code when the lifeband is not detected during operations.Possible causes include defective belt clip cabling, defective belt clip switch or removal of the lifeband from the platform during operation.Device evaluation found no anomalies with the platform which could have caused the ua 12 codes.It should also be noted that the customer indicated that the lifeband used during the event was not available for evaluation.Based on the available evaluation results, the probable cause has been determined to be removal of the lifeband from the platform by the customer during operation.Possible causes for the observed ua 17 include the brake gap being out of specification and/or the motor controller not functioning properly.Since there were no issues identified during the evaluation of the device that could have caused or contributed to this ua 17, a cause could not be determined.Based on the investigation, the part identified for replacement was the user interface membrane.In summary, the reported issue of the platform displaying a "check patient alignment" message was confirmed through platform archive review, which indicated ua 7 and 2 codes consistent with the platform displaying this "check patient alignment" message.Based on the evaluation of the device showing no related issues as well as information provided indicating that the patient was being moved to the ambulance on a stretcher while compressions were being performed, the cause of the ua 2 and ua 7 codes was determined to be misalignment of the patient while compressions were being performed.In addition to the ua 7 and ua 2 codes, ua 12 and ua 17 were also observed.The cause of the ua 12 was determined to be removal of the lifeband during operation by the customer.A cause for the ua 17 could not be determined based on the evaluation.Based on the full evaluation of the device, there were no anomalies or mechanical issues associated with the device that could have caused or contributed to the reported bruising noticed on the patient.The cause of reported bruising on the left side of the patient's back cannot exactly be determined.However, such bruising cannot be ruled out depending on the patient's alignment on the platform.The customer did report that a "check patient alignment" message was observed.There were also no issues or anomalies observed with the returned platform that could have caused or contributed to the observed ua codes.Following service, including replacement of the damaged part noted during visual inspection, the device passed all testing criteria.

• 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: 4094421
• MDR Text Key: 4832294
• Report Number: 3010617000-2014-00465
• 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: 08/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2014
• 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: CARDIAC MONITOR; AED; MANUAL CPR
• Patient Outcome(s): Other