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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the product for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

During training session, the autopulse platform displayed a user advisory (ua) 18 (max take-up revolution exceeded) error message on the user control panel.User was unable to clear the ua 18 error message.No patient involvement.

Manufacturer Narrative

The reported event could not be reproduced during evaluation of the autopulse platform (sn (b)(4)); however, review of the archive data revealed multiple user advisory (ua) ua18 (max take-up revolution exceeded) error messages on the reported event date of (b)(6) 2018, confirming the reported event.Evaluation of the platform was performed and no fault or error observed during functional testing.Note that the user advisory error messages are designed into the platform when one of several conditions is detected.The error message observed in the archive are easily clearable by user.For example ua 18 alerts the operator that during takeup, the autopulse driveshaft has moved the lifeband past the maximum allowable takeup depth without detecting a patient.This user advisory will persist until the restart button is pressed and the autopulse platform is restarted.Historical complaints were reviewed for service information related to the reported complaint and no previous history of complaint was reported for the autopulse platform with serial number (b)(4).

• 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: 7579986
• MDR Text Key: 110459925
• Report Number: 3010617000-2018-00623
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• 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: 06/20/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention