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 12/02/2018

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was evaluated and serviced in the field by zoll technical service.The reported complaint of "system error, out of service, revert to manual cpr" error message was confirmed based on the functional testing.The fault was found to be due to the defective processor board.Visual inspection was performed and no physical damages were observed.The platform failed the initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed when the platform was powered on, thus confirming the reported complaint.Following the service and repair, the autopulse was tested functionally and passed successfully with no issue or faults observed.Device history record (dhr) was reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

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

Manufacturer Narrative

The autopulse platform was evaluated and serviced in the field by zoll technical service.The reported complaint of "system error, out of service, revert to manual cpr" error message was confirmed based on the 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 unrelated to the reported complaint, found damaged top cover, in addition, encoder drive shaft does not rotate smoothly, exhibits binding and resistance and the motor drive train brake gap was out of specification.The autopulse platform is a reusable device and was manufactured in 2010 and is 8 years old.It has exceeded its expected service life of 5 years.This type of physical damage found during visual inspection is characteristic of normal wear and tear for the age of the device.The platform failed the initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed when the platform was powered on, thus confirming the reported complaint.Upon customer approval, the device will be further tested to full specification.Device history record (dhr) was reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8200934
• MDR Text Key: 131582008
• Report Number: 3010617000-2018-01277
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

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: 8700-0700-03
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/02/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/02/2018
• Supplement Dates FDA Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1