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 Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

The primary report of the autopulse platform ((b)(4)) displaying "replace battery" message was not reproduced during functional testing of platform, and could not be confirmed through review of the retrieved archive data.The archive data recorded no session around the reported event date of (b)(6) 2018.The report of the platform displaying "replace battery" was not reproduced during functional testing of platform.The secondary report of the platform's user control panel is pixilated was confirmed during functional testing.It is attributed to defective user control panel lcd.The autopulse platform is a reusable device and was manufactured on 31 jan 2013.It has exceeded its expected service life of 5 years.As part of the routine service during testing, the platform was examined and observed a defective belt clip retainer.This observation is not related to the reported complaint.It is attributed to wear and tear.After replacement of the defective user control panel lcd and belt clip retainer, the platform was functionally tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and no previous history of complaint was reported for the autopulse platform with serial number (b)(4).

Event Description

As reported, during patient use the autopulse platform ((b)(4)) displayed "replace battery" error message.User used multiple fully charged autopulse li-ion battery and error message still occurred.Additionally, the user control panel on the platform is pixilated.No known impact or patient consequence was reported.No other information was provided.

• 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: 7598547
• MDR Text Key: 111007081
• Report Number: 3010617000-2018-00620
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• 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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2013
• 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