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

Model Number MODEL 100

Device Problems Positioning Failure (1158); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 10/17/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint was confirmed during archive review and initial functional testing.The cable connector to motor controller board pin was seated correctly to remedy the fault.The platform has passed all the final functional testing.No physical damage was observed during visual inspection.The archive data review indicated multiple error message ua 16 (timeout moving to take-up position) on the customer reported complaint date of (b)(6) 2017.The autopulse platform failed the initial functional testing due to error message user advisory (ua) 16 when the start button was pressed.The cable connector to motor controller board was not seated correctly which lead to ua 16.Historical complaints were reviewed and one previous complaints was reported for this autopulse platform (sn:(b)(4)) for error message user advisory (ua) 16 reported on (b)(6) 2016 under (b)(4).The brake gap was re-adjusted to solve the ua 16.

Event Description

As reported during patient use, the autopulse platform (sn: (b)(4)) displayed an error message and the lifeband could not be retracted.The crew then reverted to manual cpr.The exact error message is not provided.The customer does not have functioning batteries; therefore they were not able to replicate the issue.The customer was not able to provide us additional information.No known patient consequences were 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7029629
• MDR Text Key: 92801747
• Report Number: 3010617000-2017-00902
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2007
• 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