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

Model Number MODEL 100

Device Problems Device Issue (2379); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 05/10/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed during functional testing, the autopulse platform did not power on due to a defective power switch cable.Review of the retrieved archive data found no significant discrepancies related to the reported complaint.As part of routine service during testing, the platform was examined and found unrelated to the reported complaint, damaged front enclosure, a bent battery lock, and an lcd screen with no backlight.Front enclosure, a battery lock, and an lcd were replaced to address the issue.The autopulse platform is a reusable device and was manufactured in 2013.This type of physical damage found during visual inspection is characteristic of normal wear and tear for the age of the device.Following the service and repair, the platform was tested for 15 minutes with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient and passed successfully with no issue or faults observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

During routine testing, the customer reported that the autopulse platform (sn (b)(4)) was unable to power on.Multiple good known autopulse li-ion batteries were inserted in the platform; however, the same issue was observed.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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 7579972
• MDR Text Key: 110459778
• Report Number: 3010617000-2018-00618
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/07/2018

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2013
• 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