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	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "ua 7 (discrepancy between load 1 and load 2 too large)" on the autopulse platform ((b)(4)) was confirmed during power on and data archive review.The load sensing system has detected a weight/load imbalance on one of the load cell.It was determined that the root cause was due to a defective load cell as a result of an aging component.To remedy the issue, the load cell was replaced.The ap platform was tested and as expected, it passed all functional tests and ready for clinical use.No physical damage observed on the ap platform during visual inspection.The autopulse platform is a reusable device and was manufactured in march 2008.The device has been operating for over 10 years and has exceeded its expected serviceable life of 5 years.Initial functional testing could not be performed due to ua 7 (discrepancy between load 1 and load 2 too large) displayed upon platform power on.Thus, confirming the reported complaint.During archive data review, error message ua 7 (discrepancy between load 1 and load 2 too large) was identified.Thus, confirming the reported complaint.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse serial number (b)(4).
Event or Problem Description
As reported, during product training, the user's autopulse platform ((b)(4)) displayed user advisory - ua 07 (discrepancy between load 1 and load 2 too large) error message.The users were unable to clear the error message.A zoll sale representative went on-site and attempted to run a simulation on a mannequin but without success.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: 7760187
• Report Number: 3010617000-2018-00808
• Device Sequence Number: 1230754
• Product Code: DRM
• UDI-Device Identifier: 00849111000314
• UDI-Public: 00849111000314
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 08/07/2018

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: 8700-0700-02-66
• 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: 07/13/2018
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1