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	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of user advisory - ua7 (discrepancy between load 1 and load 2 too large) error message on the autopulse platform (b)(4) was not confirmed during power on and during archive data review.Load cell characterization test confirmed both cell modules are functioning within the specification on the platform.The run_in test was performed using the 95% patient test fixture (lrtf) with good known test batteries until discharged without any fault or error.The ap platform passed all functional tests with no problem observed.No physical damage observed on the ap platform during visual inspection.However, the encoder drive shaft did not rotate smoothly, exhibits binding and resistance identified.To remedy the issue, the encoder drive shaft was deburred.This type of issue identified was not related to reported complaint.Initial functional testing on the ap platform passed without any fault error.During archive data review, ua7 error message was not identified on the date of the reported event.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse (b)(4).
Event or Problem Description
As reported, during shift check, the user's autopulse platform (b)(4) displayed user advisory - ua07 (discrepancy between load 1 and load 2 too large) error message.The user was unable to clear the advisory.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: 7857550
• Report Number: 3010617000-2018-00890
• Device Sequence Number: 11379858
• Product Code: DRM
• UDI-Device Identifier: 00849111000550
• UDI-Public: 00849111000550
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/07/2018

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: 8700-0730-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1