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

Model Number MODEL 100

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2014

Event Type  malfunction  

Event Description

It was reported that during a call, the autopulse platform stopped performing compressions.No adverse patient sequelae was reported.No further information was provided.Please note that the date of event was not provided.Manufacturer has requested additional information from the customer; however, no additional information has been obtained.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 10/21/2014 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 shows no physical damages to the platform.A review of the autopulse platform's archive was performed and the reported complaint of the platform stopping compressions during a call was confirmed.The archive data shows that user advisory (ua) 7 (discrepancy between load 1 and load 2 too large), ua 18 (max take-up revolutions exceeded), and ua 2 (compression tracking error) faults occurred on the reported event date of (b)(6) 2014.The archive also shows that the load imbalance between the left and the right sides of the load plate was more than 20 lbs.This occurred because a heavier load force was applied on the load plate.Functional testing was performed and the reported complaint was confirmed.Load cell characterization testing indicated that load cell module 1 was not functioning correctly.Based on the initial investigation, the part identified for replacement was load cell module 1.In summary, the reported complaint was confirmed based on the archive review and during functional test.The root cause for the ua 7 and ua 2 faults was due to the defective load cell module.The root cause for ua 18 fault could not be determined.The root cause for ua 18 fault was due to the load imbalance between the left and the right sides of the load plate.

Event Description

The initial call came in on (b)(6) 2014 at 5:47 am for a (b)(6) male patient weighing (b)(6) in cardiac arrest.The event occurred at the patient's home.The cardiac arrest was non traumatic and was unwitnessed.Patient has a medical history of diabetes and hypertension.The patient was also undergoing dialysis for renal failure.Manual cpr was performed by the police for about 6 minutes prior to arrival of the fire department.When the fire department arrived, they took over and performed manual cpr for about 1-2 minutes before using the autopulse device.During deployment of the autopulse, one side of the lifeband would not retract.The fire department turned off the autopulse, pulled up the lifeband and re-positioned the patient; however, one side of the lifeband still did not retract.The fire department made 2-3 attempts to resolve the issue but the lifeband did not function correctly.After 2-3 attempts, the fire department turned off the autopulse to replace the battery and the lifeband.After replacement of the battery and the lifeband, the platform was powered back on and the patient was repositioned.However, one side of the lifeband still did not retract.At this point, the crew discontinued use of the autopulse and reverted to manual cpr for about 5-6 minutes.Prior to transport to the hospital, the patient was shocked twice with a defibrillator and given 1000 doses of epinephrine twice.Patient then had pulseless electrical activity (pea).En route to the hospital, patient was given a third dose of epinephrine and achieved return to spontaneous circulation (rosc).The scene of event was 3.9 miles away from the hospital and it took 9 minutes to arrive at the hospital.Upon arrival at the hospital, the patient continued to have a pulse and spontaneous respiration.In the hospital, the er doctor intubated the patient.No further information was provided.

• 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: 4267571
• MDR Text Key: 5293253
• Report Number: 3010617000-2014-00613
• 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: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2004
• 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
• Patient Age: 71 YR
• Patient Weight: 100