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

Model Number	MODEL 100
Medical Device Problem Codes	Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
As reported during shift check, the autopulse platform (sn: (b)(4)) was displaying error message user advisory (ua) 16 (timeout moving to take-up position), ua 24 (timeout moving to "home" position) and "check patient positioning/alignment".A fully charged li-ion battery was used during this event, the lifeband has been changed and the customer tried to restart the platform; however, the error messages persisted.No patient involvement was reported.
Additional Manufacturer Narrative
The customer reported complaint for the autopulse platform displaying an error message user advisory (ua) 16 (timeout moving to take-up position) and 24 (timeout moving to "home" position) were confirmed during initial functional testing.The brake area was cleaned to remedy the issue.During visual inspection, unrelated to the reported complaint, a damaged head restraint, short black cover, bent battery latch lock and missing one of the load plate shoulder screw were observed.The autopulse platform is a reusable device was manufactured in 2012; therefore, this type of damage is characteristic of normal wear and tear for the life of the device.The platform failed the initial functional testing due to the brake was stuck which triggered error message ua 16 and ua 24 causing the platform to be non-functional.An additional repair and update was completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue.The short black cover, the battery latch lock, blue case and one load plate shoulder screw were replaced.The power distribution board were also replaced as part of the process, after which the platform passed all the final functional testing.Historical complaints were reviewed for service information related to the reported complaint and there was no previous complaints for autopulse sn (b)(4).

• 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: 6978615
• Report Number: 3010617000-2017-00863
• Device Sequence Number: 1130284
• Product Code: DRM
• UDI-Device Identifier: 00849111000635
• UDI-Public: 00849111000635
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2018

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: 8700-0730-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1