MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; 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	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of user advisory - ua07 (discrepancy between load 1 and load 2 too large) on the autopulse platform (serial # (b)(4)) was confirmed during archive review but not during functional testing.The investigation findings revealed that the reported issue was due to unintended user error.Unrelated to the reported complaint, a cracked top and front cover on the ap platform were observed during visual inspection.In addition, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance was also identified.To remedy these issues, the damaged top and front cover were replaced and the sticky clutch plate was deburred.The autopulse platform is a reusable device and was manufactured in january 2014.The device has been operating for 5 years and has reached its expected serviceable life of 5 years.Therefore, the damaged covers and faulty clutch plate were due to wear and tear as a result of an aging platform.During archive data review, multiple ua07 were observed.The user advisory - ua07 error message alerts the operator that the load sensing system has detected a weight/load imbalance between the two load cells.Ua07 indicated that either the patient not oriented on the autopulse platform correctly or the patient has shifted during compression.Thus, confirming the reported complaint.Functional testing was performed and the platform was subjected to the run_in test using the 95% patient test fixture (large resuscitation test fixture) with good test batteries until discharged without any fault or error.There was no device malfunction observed.The investigation verified that the drivetrain motor brake gap was within the specification.A load cell characterization check was performed and confirmed that both load cell modules are functioning within the specification.The autopulse platform is ready for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there were no previous history of complaints reported for autopulse with serial number (b)(4).
Event or Problem Description
During shift check, customer reported that the autopulse platform (serial # (b)(4)) displayed a user advisory - ua07 (discrepancy between load 1 and load 2 too large) error message.The error message could not be cleared by the user.No patient involvement.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8345346
• Report Number: 3010617000-2019-00122
• Device Sequence Number: 1923841
• Product Code: DRM
• UDI-Device Identifier: 00849111001533
• UDI-Public: 00849111001533
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 02/15/2019

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: 8700-0780-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 02/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1