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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint for the autopulse platform damaged front enclosure was confirmed during the visual inspection.The cracked front enclosure was likely attributed to mishandling such as a drop.The front enclosure was replaced to address the physical damage.During functional testing, user advisory (ua) 07 error message displayed upon power on the device, unrelated to the initial customer reported complaint.The root cause for the user advisory (ua) 07 error message was due to defective load cells.The cracked front enclosure and defective load cells were likely attributed to mishandling such as a drop.The autopulse platform failed the load cell characterization check.The load cells were replaced to address the user advisory (ua) 07 error.Upon further testing, unrelated to the reported complaint, observed damaged belt switch cable and the drive train motor brake gap was wide, out of specification as a result of normal wear and tear for the age of the device.The belt switch cable was replaced and the brake gap was adjusted to remedy the fault.The autopulse platform is a reusable device and was manufactured in january 2011 and is more than 9 years old, well beyond the expected service life of 5 years.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(4).
Event or Problem Description
The autopulse platform (sn (b)(4)) was returned for the damaged front enclosure observed during the shift check.As part of routine service, the device was tested and during initial power-up, displayed user advisory (ua) 07(discrepancy between load 1 and load 2 too large) error message on the user control panel.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
• MDR Report Key: 10142040
• Report Number: 3010617000-2020-00575
• Device Sequence Number: 11348458
• Product Code: DRM
• UDI-Device Identifier: 00849111000079
• UDI-Public: 00849111000079
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 06/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1