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 05/03/2018

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; the root cause was due to a defective processor board.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.The archive data was unable to be downloaded and a review was not performed.It was indicated that the processor board was defective.The autopulse platform is a reusable device and was manufactured on 09 jul 2007.It has exceeded its expected service life of 5 years.As part of routine service during testing, the platform was further examined and found damaged top cover, motor cover, encoder cover and both head restraint wire loop.These types of physical damages found during visual inspection are characteristic of normal wear and tear for the age of the device.This observation is not related to the reported event.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial (b)(4).

Event Description

During shift check, the autopulse platform ((b)(4)) displayed a "system error, out of service, revert to manual cpr" message upon power up.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; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7563548
• MDR Text Key: 109887671
• Report Number: 3010617000-2018-00595
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2007
• 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