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

Model Number MODEL 100

Device Problems Retraction Problem (1536); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

Event Date 05/14/2015

Event Type  malfunction  

Event Description

It was reported that during patient use on a (b)(6) cardiac arrest patient, the autopulse platform displayed a user advisory (ua) 18 (max take-up revolutions exceeded) message.The user extended the lifeband to its maximum positon, but the lifeband was unable to retract.The user reverted to manual cpr (exact length of time was not provided).The patient subsequently expired.No further information was provided.Manufacturer has made several attempts to obtain additional information from the customer, however no additional details have been obtained.

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and no physical damages were observed.A review of the platform's archive data was performed and found multiple user advisory (ua) 18 (max take-up revolutions exceeded) messages on the reported event date of (b)(6) 2015.Per autopulse® maintenance guide (p/n 11653-001), ua18 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.At the time that this ua was exhibited, there was no recorded load change.The customer's reported complaint was not duplicated during functional testing.The platform passed a load cell characterization test, which confirmed that both load cells were functioning within specification.After load cell characterization testing, the platform ran with a 95% patient test fixture (lrtf) for several hours with no issues observed.The autopulse passed all testing requirements.No device deficiencies were found with the platform that may have been contributory to the ua 18.A root cause could not be determined.Based on the investigation, the parts identified for replacement were the front and bottom covers and the clutch plate.In summary, the customer's reported complaint that the platform displayed a user advisory 18 message was confirmed during review of the platform's archive data.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the reported event.The platform passed load cell characterization testing, which confirmed that both load cells were functioning within specification.The platform passed all final functional testing criteria.Based on the information received from the customer, the crew reverted to manual cpr, after the platform displayed a user advisory (ua) 18 message, which is a standard of care.Autopulse is adjunct to manual cpr.In case of stoppage of autopulse the user reverts to manual cpr.The patient's death is likely attributed to the patient's condition of cardiac arrest.

• 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: 4822629
• MDR Text Key: 5844646
• Report Number: 3010617000-2015-00321
• 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: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2007
• 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: 68 YR