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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of ua 45 (not at "home" position after power-on/restart) error message on the autopulse platform (sn (b)(4)) was confirmed during device power on and data archive review.It was determined that the root cause was due to the driveshaft not being at the "home" position as a result of user error.To remedy the issue, the driveshaft was rotated back to home position by using the administrative menu.The ap platform was tested and as expected, it passed all functional tests and ready for clinical use.Per the autopulse resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on.A user advisory - ua45 will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory - ua45, pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.During visual inspection, a damaged load plate cover was identified.This type of damage on the ap platform can occur due to normal wear and tear.The damaged part was replaced and unrelated to the reported complaint.The autopulse platform is a reusable device and was manufactured in august 2009.The device has been operating for 9 years and has exceeded its expected serviceable life of 5 years.During archive data review, multiple errors ua 45 (shaft not at "home" position) identified.Thus, confirming the reported complaint.Initial functional testing could not be performed due to ua 45 (not at "home" position after power-on/restart) displayed upon platform power on.Thus, confirming the reported complaint.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse serial number (b)(4).(b)(4) reported on (b)(6) 2014.The driveshaft was rotated to 'home" position to remedy the issue.
Event or Problem Description
As reported, the user's autopulse platform (sn (b)(4)) displayed a user advisory - ua 45 (driveshaft not at "home" position after power-on/restart) error message on the control panel.The user was unable to clear the error message.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7764995
• Report Number: 3010617000-2018-00812
• Device Sequence Number: 1318829
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2018

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1