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

Model Number	MODEL 100
Medical Device Problem Codes	Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The report of the autopulse platform ((b)(4)) displaying a system error, out of service, revert to manual cpr message was confirmed during functional testing and archive data review; the root cause was due to a defective processor board.The archive data was reviewed and contained a system error 132 (internal watchdog timeout) error message.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message on the user control panel due to a defective processor board.After replacement using a known good processor board.Further functional testing was performed by replacing using a known good processor board, this cleared the system error, out of service, revert to manual cpr message; however, the platform displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message after it was powered back on.This is due a defective load cell and is not related to the system error, out of service, revert to manual cpr message.The processor board and load cell were replaced and the device passed full specification.The autopulse platform is a reusable device and was manufactured in 16 apr 2009.It has exceeded its expected service life of 5 years.Historical complaints were reviewed for service information related to the reported complaint and no similar complaint was reported for the autopulse platform with serial number (b)(4).
Event or Problem Description
During shift check, the autopulse platform ((b)(4)) displayed an unspecified user advisory message and then "system error, out of service, revert to manual cpr" message on the display screen.The user was not able to clear the error message.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 95131
• MDR Report Key: 7524695
• Report Number: 3010617000-2018-00551
• Device Sequence Number: 1626557
• Product Code: DRM
• UDI-Device Identifier: 00849111001274
• UDI-Public: 00849111001274
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial
• Report Date (Section B): 05/17/2018

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: 8700-0740-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1