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 05/24/2018

Event Type  malfunction  

Manufacturer Narrative

The product was returned to zoll on 06/14/2018 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

As reported, the autopulse platform (sn (b)(4)) displayed ua45 (not at "home" position after power-on/restart) error message while being used on a patient.User claimed turning the device off/on and replacing the lifeband did not successfully cleared the error message.Therefore, the user initiated manual cpr.No known impact or consequence to patient.

Manufacturer Narrative

The reported complaint of user advisory error message ua45 (not at "home" position after power-on/restart) on the autopulse platform (sn 20749) was confirmed during functional test and archive data review.The encoder drive shaft does not rotate smoothly, exhibits binding and resistance.It was determined that the root cause was due to a driveshaft not at home position.To remedy the issue, the shaft was rotated to home position by using the administrative menu.Initial functional testing could not be performed due to ua45 (not at "home" position after power-on/restart) displayed upon platform power on.During archive data review, error message ua45 was identified multiple times.Thus, confirming the reported complaint.During visual inspection, cracked front and bottom covers and cracked top along with heavily frayed wire strand were observed (unrelated to the reported complaint).These types of physical damages on the device can occur due to normal wear and tear.As part of routine service, the damaged parts were replaced.The autopulse platform is a reusable device and was manufactured in august 2007.The device has been operating nearly 11 years and has exceeded its expected serviceable life of 5 years.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint for autopulse 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: 7644290
• MDR Text Key: 112566565
• Report Number: 3010617000-2018-00674
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• 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: 06/14/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1