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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the platform having a concave power button was confirmed during visual inspection and initial functional testing.The power switch was replaced to remedy the fault.During visual inspection, loose battery clip, cracked screw support of top cover and concave power button were noted.Also, the brake gap was out of specification.The autopulse platform is a reusable device and was manufactured in 2010 therefore, this type of damage is characteristic of normal wear and tear for the life of the device.During initial functional testing, the platform did not power on due to the concave power button.Load characterization was performed and both cell modules are working within specification.An additional repair and update was completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue.The power distribution board (pdb) was not up to date; therefore was replaced.The brake gap and the battery clip were adjusted.The screw support of top cover was fixed, after which the platform passed all the final functional testing.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for autopulse sn (b)(4).

Event Description

As reported during shift check, the autopulse platform (sn: (b)(4)) has a concave power button and was not working.No patient involvement was reported.

• 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: 6866942
• MDR Text Key: 86439612
• Report Number: 3010617000-2017-00718
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2010
• 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