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 Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event could not be reproduced during evaluation of the autopulse platform ((b)(4)); however, review of the archive data revealed 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.As part of routine service during testing, the platform was examined and a cracked front cover was observed.Additionally, the drive shaft exhibits binding and resistance.The observed physical damages are attributed to the normal wear and tear, it is unrelated to the reported event.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 similar complaint was reported for the autopulse platform with serial number (b)(4).

Event Description

During patient use, the autopulse platform displayed a"pull up on band and press restart" message.The user performed troubleshooting by lifting the lifeband to fullest extension ensuring no obstruction and restarting the platform; however, this did not resolve the issue.Following this, another platform was used on the patient with no further issue reported.The reporter was unable to specify the error message observed.No known impact or patient consequence was 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 INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7527299
• MDR Text Key: 108690356
• Report Number: 3010617000-2018-00563
• 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: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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: 04/25/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• 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