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	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (sn: (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message" was confirmed during the functional testing and based on the archive data review.The root cause for the occurrence of ua07 error was due to a defective load cell module 2 a result of damage sustained by user mishandling.During visual inspection of the returned platform, it was observed that the head restraint wire was broken off.Also, the front covered was noted cracked.The observed physical damages were unrelated to the reported complaint, and the root cause could be due to normal wear and tear or could be due to user mishandling.The autopulse platform is a reusable device and was manufactured in january 2008 and is 12 years old, well beyond its expected service life of five years.A review of the autopulse platform archive was performed, and it showed occurrence of multiple ua07 on the reported complaint date; thus, confirming the reported complaint.During functional testing, upon powering up the platform, ua07 was displayed.Therefore, the reported complaint was confirmed.During power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.Load cell characterization results confirmed load cell module 2 over reported/defected.The load cell module 2 was replaced to remedy the occurrence of ua07 error message.Following service, the autopulse platform passed the final testing without any fault or error.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.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 shift check, the autopulse platform (sn: (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.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
• MDR Report Key: 9830931
• Report Number: 3010617000-2020-00266
• Device Sequence Number: 13638345
• 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: 02/28/2020
• 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