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 02/05/2018

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.As part of routine service during testing the device was further examined and found no other issue.No discrepancies were found in the archive data.After replacement of the power switch cable, the platform was further functionally tested and passed all required specifications.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaints for autopulse sn (b)(4).

Event Description

The autopulse platform (sn: (b)(4)) did not power on as expected during shift check.There was no patient involvement.

Manufacturer Narrative

The customer reported issue was confirmed during the archive data review of the autopulse platform (sn (b)(6)) (refer mfr 3010617000-2019-00212).There were no device deficiencies found during the evaluation of the battery (sn (b)(6)).Upon visual inspection, no physical damage was observed and four green lights were lit on incoming inspection.The battery passed charging in a known good autopulse multi-chemistry charger.Four green lights were lit on the battery after the charging attempt.The archive data review showed that the battery recorded over-current detected error.The error triggered the battery to open its onboard fets (field-effect transistor) as safety measure.The probable cause for the error could be due to the seized motor in the autopulse platform or due to the autopulse platform demanding excessive current during the operation.The battery was then reconditioned and fully charged.

Event Description

Please see the following related mfr report: mfr # 3010617000-2019-00212 for the autopulse platform.Mfr # 3010617000-2019-00222 for the 1st autopulse li-ion battery.

• 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: 7319313
• MDR Text Key: 101843429
• Report Number: 3010617000-2018-00223
• 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: 04/17/2019

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: 03/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1