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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 04/17/2018

Event Type  malfunction  

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 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
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7524695
• MDR Text Key: 108618046
• Report Number: 3010617000-2018-00551
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001274
• UDI-Public: 00849111001274
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1