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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of ua12 was confirmed during archive data review of the autopulse platform ((b)(4)); however, could not be reproduced during functional testing.Therefore, the cause of the ua12 could not be determined.The ua45 was confirmed during initial functional testing and review of the archive data.To resolve the ua45 issue, the shaft was rotated to the home position.During evaluation, the platform's band clip functioned as intended without issue.The autopulse platform is a reusable device and was manufactured in 3/13/2008.Therefore, this type of issue is characteristic of normal wear and tear for the life of the device.Review of the archive data revealed multiple ua12 and ua45 on the reported event date of (b)(6) 2017.The initial functional testing could not be performed due to ua45 upon powering on the platform.During visual inspection (unrelated to the issue) the front enclosure was found damaged and the drive shaft stiff (due to sticky clutch plate).Upon customer approval, the components will be replaced and the device will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and (b)(6) were reported for a ua45 with serial number (b)(4).To avoid the re-occurrence of ua45, the encoder gearbox was replaced.

Event Description

As reported, the autopulse platform (sn: (b)(4)) displayed a user advisory 12 and user advisory 45 during a shift check.Additionally, it was observed that the platform's band clip does not function properly.To troubleshoot, the reporter placed a mannequin on the platform and restarted the device; however, issue continued.There was 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 ; 4084192955
• MDR Report Key: 6802336
• MDR Text Key: 83110308
• Report Number: 3010617000-2017-00613
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2017

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: 08/03/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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