MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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	02/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint for the platform displaying an error message "analyzing patient size" and a fault 08 (motor controller fault detected) was confirmed during archive review and initial functional testing.The root cause was due to a defective drive train motor.Unrelated to the reported complaint, a damaged load plate cover was observed during visual inspection.The load plate cover needs a replacement to address the issue.This type of physical damage found during visual inspection is characteristic of user mishandling.The autopulse platform failed initial functional testing due to fault 08 (motor controller fault detected) displayed upon powering on.The motor controller's built-in fault detection system signals a fault due to defective drive train motor.The drive train motor was replaced to remedy the fault 08 error message.Review of the archive data indicated multiple fault 08 error messages on the customer reported event date.The load cell characterization test confirmed both load cell modules are functioning within the specification.Following the repair, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse platform sn (b)(4).
Event or Problem Description
During a shift check, the autopulse platform (sn (b)(4)) displayed the user advisory (ua) 45 (not at "home" position after power-on/restart) error message.The customer was able to clear the error, however, the platform displayed "analyzing patient size" and a fault (ua) 08 (motor controller fault detected) after the restart.The customer was unable to clear the errors.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose, ca
• MDR Report Key: 9814288
• Report Number: 3010617000-2020-00235
• Device Sequence Number: 1551596
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2020

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: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1