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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform ((b)(4)) displaying a system error message was confirmed during functional testing and archive data review; the root cause was due to a defective processor board.The autopulse platform is a reusable device and was manufactured on 09 may 2012 it is approaching expected service life of 5 years.The platform has not seen regular preventive maintenance.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message on the display screen.It was indicated that the processor board was defective.The archive data was reviewed and contained a system error 132 (internal watchdog timeout) error message on the customer reported event date of (b)(6) 2018.As part of routine service during testing, the platform was examined and found physical damage.The observed physical damage is attributed to the normal wear and tear due to the age of the device, it is unrelated to the system error message.Upon replacement of the processor board and the damaged component, the platform was further tested and passed the testing.The platform operated with continuous compression without any issues or further error messages observed.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

As reported during shift check, the autopulse platform ((b)(4)) was displaying error message "system error, out of service, revert to manual cpr" when powered on.No patient involvement was reported.

• 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; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7448826
• MDR Text Key: 106307025
• Report Number: 3010617000-2018-00463
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2018

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2012
• 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