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 No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the platform displayed a user advisory (ua) 12 (lifeband not present) error message was not confirmed during functional testing but was confirmed during archive data review.Analysis of the autopulse platform revealed no problems with the board which may have contributed to the reported complaint.Visual inspection was performed and found cracked front cover, unrelated to the reported complaint.Front cover was replaced to address the issue.During run_in test, unrelated to the reported issue, the platform stop compressions due to system error 139 (unable to hold compression position).The root cause of the issue was due to the drive train motor brake gap assembly was out of specification.After adjusting the brake gap, the autopulse was subjected to the run in test using 95% patient large resuscitation test fixture for 30 minutes and passed with no issue or faults observed.Review of the archive data indicated multiple user advisory (ua) 12 error message on (b)(6) 2018.The lifeband clip detect switch inspection was performed and verified that the switch closed and the switch lever is parallel to the switch case.In addition, ensured two screws holding the switch lever parallel to the switch case were not missing and were tightened correctly.Per the archive data, a user advisory (ua) 19 (max applied load exceeded) error message was recorded on the same day as the load plate detected excessive weight being applied (the patient weight exceeding 312 lbs) on the platform.User advisory (ua) 19 error message observed in the archive data is easily clearable by user.Per the autopulse user guide instructions, the error messages can be cleared by using a fully charged autopulse battery and restarting the platform.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

As reported, during patient use, the autopulse platform ((b)(4)) displayed user advisory (ua) 12 (lifeband not present) error message.No additional information was provided.No patient consequence was reported.Date of event is unknown.

• 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: 7489175
• MDR Text Key: 107608667
• Report Number: 3010617000-2018-00519
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2014
• 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