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

Model Number MODEL 100

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/16/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform displayed a user advisory 7 (discrepancy between load 1 and load 2 too large) message that could not be cleared by powering the device off and on.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2014 for investigation.Investigation results as follows: visual inspection was performed and the following was observed: the top cover, front enclosure and bottom enclosure were cracked.From the condition of the returned platform, the damages appear to be due to wear and tear.The reported user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message was observed during power on of the platform.No further functional testing could be performed due to the constant ua 7 fault.Further inspection determined that the cause of the ua 7 fault was that one of the load cells was not functioning properly.The archive did not show any ua 7 faults occurring on the reported event date of (b)(4) 2014, however there were multiple ua 7 messages on other dates, including the latest occurrence on (b)(4) 2014.Based on the investigation, the part(s) identified for replacement is the load cell module.In summary, the reported complaint of a ua 7 fault occurring was confirmed through archive review as well as during functional evaluation.Further inspection determined the cause of the ua 7 to be a load cell not functioning properly.

• 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: 3932289
• MDR Text Key: 20266422
• Report Number: 3003793491-2014-00332
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• 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: 06/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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