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

Model Number	MODEL 100
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform (s/n: (b)(4)) was returned for evaluation.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for autopulse sn (b)(4).During visual inspection, broken/cut top cover head restraint wires were noted.Autopulse is a reusable device and was manufactured in 02/11/2010.The damage found is characteristic of normal wear and tear for the life of the device.During archive date review, multiple user advisory (ua) 7 (discrepancy between load1 and load2 too large) were noted (unrelated to the reported complaint).Functional testing could not be performed, since ua 7 error message appeared when the platform was powered on.Load cell characterization test confirmed both load cell modules were defective.In summary, visual inspection confirmed the customer complaint of the top cover head restraint wires were broken/cut.An additional repair and update was completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue.Top and front covers, both load cell modules, belt retainer and wave springs were replaced.The platform passed all final testing criteria.
Event or Problem Description
It was reported that the loaner autopulse platform (sn: (b)(4)) top cover's wire strands were broken off.During investigation, multiple user advisory 07 (discrepancy between load 1 and load 2 too large) error message were displaying.No patient involvement was reported.

• 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: 6146666
• Report Number: 3010617000-2016-00855
• Device Sequence Number: 18948719
• Product Code: DRM
• UDI-Device Identifier: 00849111065108
• UDI-Public: 00849111065108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/05/2016

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2016
• Initial Report FDA Received Date: 12/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1