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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2017

Event Type  malfunction  

Manufacturer Narrative

The customer complaint of stopped compression and a "lifeband to be reposition" message was confirmed during a review of the platform's archive data.However, the reported issue could not be reproduced during functional testing.Since the issue could not be replicated and no device deficiencies were found that could have caused or contribute to the reported "lifeband to be repositioned" issue, the root cause of the customer complaint could not be determined.The autopulse platform is a reusable device and was manufactured in february 2016.Visual inspection was performed and no physical damages were found.During functional testing, a run-in test was performed and no faults were observed.According to the platform's retrieved archive data, the autopulse battery (sn: (b)(4)) used at the time of the event was fully charged and the platform provided compressions on a medium size patient.Multiple stopped compressions due to a user advisory 17 error (thus resulting in the "lifeband to be repositioned" message) were recorded.User advisory 17 is an indication that the lifeband is twisted or battery voltage is low.The errors were cleared by the customer.The platform automatically powered off after (b)(4) compressions.Device history record (dhr) was 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 patient use, it was reported that the autopulse platform (sn: (b)(4)) stopped after 6-8 compressions and displayed a message to reposition the lifeband.According to the reporter, after the lifeband was pulled up, the platform continued to provide compressions.Approximately 10-12 minutes into the cardiac arrest, the reporter indicated the platform powered off on its own and despite two attempts, the platform would not power back on.The reporter reverted to manual cpr while the secondary autopulse battery was retrieved.After the secondary battery was inserted, the platform powered on and began to provide compressions.However, the same events occurred a second time.According to the reporter, the platform again stopped after 6-8 compressions and displayed a message to reposition the lifeband.After the lifeband was pulled up and the platform restarted, the platform provided approximately 10-12 minutes of compressions, until it once more automatically powered off.The reporter reverted to manual cpr and continued to provide manual compressions during hospital transport.At an unspecified time after the event occurred, the reporter rechecked the initial battery.The battery indicator displayed that it was fully charged.With the secondary battery still in the platform, the reporter indicated the platform still would not power on.The reporter removed the secondary battery from the platform and found that it too was still fully charged.Per the reporter, the platform powered back on after the battery was reinserted.There is no further patient information provided.There is no known patient consequences 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6698832
• MDR Text Key: 79647161
• Report Number: 3010617000-2017-00462
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: Health Professional
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2016
• 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