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

Model Number MODEL 100

Device Problem Break (1069)

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

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.No information can be 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.Visual inspection of the returned platform was performed and found the lcd backlight to not be functioning.Initial functional testing of the platform was performed and no faults or errors were exhibited.A review of the archive was unable to be performed as the archive was unable to be downloaded because the ir and serial ports of the processor pca board were defective.The processor pca board was replaced remedying the customer's reported complaint.The platform underwent and met all final testing criteria.The customer's reported complaint of the lcd backlight not functioning was confirmed through visual inspection of the platform.The root cause was determined to be a defective processor pca at the lcd backlight input.The processor pca board was replaced, remedying the customer's reported complaint.

• 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: 3900865
• MDR Text Key: 4546183
• Report Number: 3003793491-2014-00295
• 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

• 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
• Initial Date Manufacturer Received: 07/25/2014
• Initial Date FDA Received: 06/27/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2008
• 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