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 Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll on 03/20/2018 for investigation; however, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

An unspecified issue was reported on the autopulse platform (sn (b)(4)) during patient use.No known impact or patient consequence was reported.The reporter was unable to provide further information.

Manufacturer Narrative

The reported complaint was not confirmed.There were no device deficiencies found during evaluation of the returned autopulse platform ((b)(4) to indicate a functional issue.Review of the archive data found no session on the reported event date or any device issue.The platform was functionally tested using a good known autopulse li-ion battery with a large resuscitation test fixture and operated with compression without any issue or error message observed.The evaluation verified that the drivetrain motor brake gap was within the specification.A load characterization check was performed and confirmed that both load cell modules are functioning within the specification.As part of routine service during testing, the device was examined and found physical damage.Additionally the driveshaft was exhibiting binding and resistance.These observations are unrelated to the reported event.After replacement of the physically damaged part, the clutch plate was deburred and the device was further functionally tested and operated as expected without issue.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with (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: 7387094
• MDR Text Key: 104042219
• Report Number: 3010617000-2018-00393
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• 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?: Yes
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1