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

Model Number MODEL 100

Device Problems Break (1069); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

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

Event Date 12/09/2013

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform displayed a user advisory 7 (discrepancy between load 1 and load 2 too large) message upon power on.The message was unable to be cleared by powering the platform off and on.Customer also noted that there is nothing on the platform and also reported that one of the head restraints is damaged.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/09/2014 for investigation.Investigation results as follows: the reported problem was confirmed.Visual inspection of the platform shows the head restraint wire was cut/broken.Probable cause of this issue may be due to customer's mishandling of the platform.The reported problem of user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was not confirmed to have occurred on the reported event date of (b)(6) 2013.However, review of the archive data shows ua07 occurred on (b)(6) 2013.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." per the battery hangtag - advisory codes description and action (pn 12741-001), user advisory 7 is an indication that the patient is out of position or the patient is not properly centered.The recommended actions to take for this type of user advisory are to: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.Note: utilizing the shoulder restraints may help prevent changes in patient alignment.The ua07 could not be reproduced during functional testing as the platform ran with the test manikin for 15 minutes without any problems.In addition, both load cells are functioning normally.

• 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: 3575536
• MDR Text Key: 16684764
• Report Number: 3003793491-2014-00019
• 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: 12/23/2013

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: 01/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2007
• 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