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

Model Number MODEL 100

Device Problems Failure to Align (2522); Device Displays Incorrect Message (2591)

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

Event Date 12/31/2013

Event Type  malfunction  

Event Description

Complainant alleged that during patient use, the autopulse® resuscitation system would not provide continuous compressions.The autopulse performed one compression, stopped and displayed a "realign patient" message.Customer attempted to realign the patient to the designated area on the platform, however this did not resolve the issue.No adverse patient sequelae was reported.No further details were provided.

Manufacturer Narrative

Customer also reported that after the incident, the autopulse was tested with a mannequin and the same issue occurred.The autopulse platform (b)(4) was returned for evaluation.The reported complaint of the platform stopping compressions and displaying a message stating "realign patient" could not be confirmed.The platform was run for 20 minutes with a test mannequin and an additional 7 minutes with a lrtf (large resuscitation test fixture) and no faults were found.A review of the archive shows that on (b)(6) 2013, numerous user advisory 2 faults (compression tracking error) had occurred and that a small patient or object was used on the platform.Per the autopulse® resuscitation system model 100 user guide (pn: 12555-001), "the autopulse enters a user advisory state or the fault state when one of several conditions is detected.A user advisory generally indicates that a misalignment or inappropriate movement of the patient or the lifeband has occurred.A fault generally indicates that the autopulse has detected an inappropriate internal condition.Both conditions are typically correctable by the operator.Follow the instructions on the screen and then attempt to restart active operation by pressing the start/continue button." as this fault occurred approximately one month prior to the reported event date of (b)(6) 2013, it is deemed unrelated to the reported complaint.

• 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: 3586053
• MDR Text Key: 4165769
• Report Number: 3003793491-2014-00038
• 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
• Report Date: 12/31/2013

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/31/2013
• Initial Date FDA Received: 01/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2006
• 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