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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "system error, out of service, revert to manual cpr" error message was confirmed based on the archive review and during functional testing.The fault was found to be due to the defective processor board.As part of routine service during testing, the platform was examined and found damage encoder and motor covers, unrelated to the reported complaint.The encoder and motor covers were replaced to address the issue.The autopulse platform is a reusable device and was manufactured in 2005, and is 13 years old, well beyond the expected service life of five years.Therefore, this type of physical damages found during the visual inspection are characteristics of normal wear and tear for the life of the device.During functional testing, the platform was powered on and the system error, out of service, revert to manual cpr error message appears on the display panel.A review of the archive was performed and the archive data shows system error 136 - internal parameter corrupted, thus confirming the reported complaint.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse platform with (b)(4), reported on (b)(6) 2015, processor board was replaced.

Event Description

During shift check, the autopulse platform ((b)(4)) displayed an error message "system error, out of service, revert to manual cpr." no patient was involved.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 8188043
• MDR Text Key: 131323965
• Report Number: 3010617000-2018-01271
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2018

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2005
• 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