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

Model Number MODEL 100

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591)

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 user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message was confirmed during functional testing and archive data review.The platform is a reusable device and was manufactured on 30 jun 2007 and has exceeded its expected service life of 5 years.The platform is almost 11 years old and has not seen regular preventive maintenance.The platform was functionally tested and upon power up, it displayed a ua 7 error message on the user control panel.It was identified that the load cell is defective.The root cause of the ua 7 error message was attributed to this issue.Review of the retrieved archive data shows no session occurred on the reported event date of (b)(6) 2018.However, the archive date showed the last use of the auto pulse platform was on (b)(6) 2017 which displayed multiple ua7 error messages.As part of routine service during testing, the platform was further examined and found physical damage.This is unrelated to ua 7 error message.Upon customer approval, the damaged parts as well as the load cells will be replaced.The platform will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and no similar complaint reported for autopulse platform with serial number (b)(4).

Event Description

As reported, during shift check the autopulse platform ((b)(4)) displays error message user advisory (ua) 7 (discrepancy between load 1 and load 2 too large).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: 7524071
• MDR Text Key: 108618699
• Report Number: 3010617000-2018-00499
• 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: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2018
• 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: 04/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2007
• 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