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

Model Number MODEL 100

Device Problems Break (1069); Image Display Error/Artifact (1304)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2014

Event Type  malfunction  

Event Description

It was reported that during inspection, it was found that the autopulse platform's display was damaged.The information on the display is not clearly seen.Other than this, the device works fine.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 06/30/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows that the user interface (ui) membrane was damaged.The physical damage found during visual inspection confirmed the reported issue that the information on the display was not clearly seen.The damage appears to have been caused by normal wear and tear (autopulse manufactured in may of 2011).A review of the autopulse archive was performed and the archive data shows that no clinical use with a patient occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the platform passed the initial system test.In addition, the ui window was observed to be scratched during testing of the platform which confirmed the reported issue that the display was damaged.Based on the investigation, the parts identified for replacement were the ui membrane and the ui window.In summary, the reported complaint that the information on the display was not clearly seen was confirmed during visual inspection.The fault was found to be due to the damaged ui membrane.The reported issue of the display being damaged was confirmed during functional testing of the platform.The damage was found to be a scratched ui window.Upon replacement of all parts, the platform was re-evaluated through functional testing and passed all testing criteria.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3900961
• MDR Text Key: 4429919
• Report Number: 3003793491-2014-00296
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Paramedic
• Type of Report: Initial,Followup
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• 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: 06/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2011
• 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