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

Model Number MODEL 100

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 12/29/2014

Event Type  malfunction  

Event Description

It was reported that during use on a (b)(6) male patient, the autopulse platform displayed user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) and/or ua 17 (max motor on time exceeded during active operation) messages.Patient was (b)(6) and weighed (b)(6).Customer indicated that the patient was properly positioned on the platform.It was also reported that the platform shut down after performing 30 compressions.Customer made two attempts to restart the platform but the platform did not restart.The patient reportedly died; however, the customer does not attribute the patient's death to the autopulse.Manufacturer has requested additional information from the customer; however, customer could not provide any further information.

Manufacturer Narrative

The autopulse platform in complaint was initially returned to zoll (b)(4) on 01/09/2015 and was then sent to zoll (b)(4) for investigation.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll (b)(4) on 02/17/2015 for further investigation.Investigation results as follows: visual inspection of the returned platform was performed and found that the top cover and motor covers were cracked.The platform was turned on/off with no problems and underwent run-in testing using a 95% patient test fixture for several hours, with no anomalies or errors exhibited.The platform also underwent and passed load cell characterization testing, confirming that both load cells were functioning properly.In addition, a brake gap inspection was performed, which verified that the brake gap was within the specification of 0.008" ±0.001".A review of the platform's archive was performed and found multiple user advisory (ua) and warning messages on the reported event date of (b)(6) 2014: warning 1 (low battery warning), ua 2 (compression tracking error), ua 7 (discrepancy between load 1 and load 2 too large), ua17 (max motor on time exceeded during active operation) and ua 18 (max take-up revolutions exceeded).Warning 1 is exhibited to let the customer know that the battery needs to be changed.Per the autopulse® maintenance guide (p/n 11653-001), ua 2 is exhibited when the platform detects a change in lifeband tension.This advisory happens when either 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 7 is exhibited when the platform detects that the patient is not properly centered.Per the autopulse® maintenance guide (p/n 11653-001), ua 17 typically occurs when the lifeband® is twisted, or the battery voltage is low.It should be noted that li-ion battery with serial number (sn): 5421 was used with high remaining capacity when the ua 17 message occurred.Per the autopulse® maintenance guide (p/n 11653-001), ua 18 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 the reported event occurred during patient use.The autopulse® was designed to exhibit ua's to prevent patient harm.Please note that there were no mechanical issues identified with the platform which could have caused or contributed to these user advisory codes.No parts were replaced to remedy the customer's reported complaint of the platform exhibiting a ua 7 and/or ua 17 message.Unrelated to the reported complaint, the damaged top cover and motor covers found during visual inspection were replaced.The platform then underwent and passed all final functional testing.In summary, the customer's reported complaint of the platform exhibiting a ua 7 and/or ua17 message was confirmed through review of the platform's archive data.The root cause of both ua's was determined to be use error, as neither messages were replicated during testing of the platform.

• 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: 4481517
• MDR Text Key: 5570083
• Report Number: 3010617000-2015-00069
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2015

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: 8700-0700-02-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2006
• 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: 75 YR
• Patient Weight: 80