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 Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (serial #(b)(4)) displayed "realign patient" error message was not confirmed during power on.However, the lcd backlight was dark, not illuminating.Thus confirming the secondary customer reported complaint.The root cause of the backlight issue was due to defective processor board as a result of normal wear ad tear.The returned autopulse platform was manufactured in july 2009 and it is over 10 years old, well past beyond its expected serviceable life of 5 years.No physical damage was observed on the returned autopulse platform during visual inspection.However, unrelated to reported complaint, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to sticky shaft.Deburring of the sticky shaft to remedy the issue.This type of a faulty component is likely attributed to normal wear and tear.During archive data review, ua02 (compression tracking error) was recorded around the reported event date.Thus, confirming the reported complaint.During load cell characterization test, the autopulse platform stopped compression repeatedly with ua02 error message.The load sensing system has detected a weight/load imbalance between the two load cells during compression.The root cause of ua02 error was due to a defective load cell module 2 as a result sustained by mishandling.Upon replacing load cell module 2, the platform was re-evaluated through another run_in test, using the 95% patient test fixture (lrtf) with good known test batteries until discharged 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 with serial number (b)(4).
Event or Problem Description
During patient use, customer reported that the autopulse platform (serial #30739) displayed "realign patient" error message.Also, the backlight on the lcd was defective.No consequences or impact to patient.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 9831555
• Report Number: 3010617000-2020-00262
• Device Sequence Number: 10947777
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2020

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: 02/26/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1