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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

The report of a user advisory (ua) 12 (lifeband not present) was confirmed based on the functional testing and archive data review of the autopulse platform (sn (b)(4)).The root cause is due to the switch lever not being able to close and not being parallel to the switch case.The platform was functionally tested and displayed a user advisory (ua) 12 (lifeband not detected) error message during power up.Following this, a lifeband clip detect switch inspection was performed where it was indicated that the switch lever is not able to close and is not parallel to the switch case, causing the ua 12 error message to occur.After readjustment of the switch lever and verification using a standard belt test clip aid, the platform was further tested and operated as intended without any further issue fault or error.The platform passed all testing criteria and met all required specifications.The archive data was reviewed and contained a ua 12 error message.Historical complaints were 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 a training session at the customer site, the autopulse platform (sn (b)(4)) displayed multiple incidence of user advisory (ua) 12 (lifeband not present) error messages.After inspection, it was noted that the lifeband clip does not stay in place.No patient was involved with this event.This references the report of ua 12 error messages displayed by the platform.The report of the lifeband unable to properly fit in the platform is referenced under mfr 3010617000-2018-00353.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7368197
• MDR Text Key: 103723922
• Report Number: 3010617000-2018-00336
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• 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: 03/06/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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