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

Model Number MODEL 100

Device Problems Material Separation (1562); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform displayed a "system error, out of service" message upon power up.Customer also noted that the upper and lower housing of the platform was starting to separate.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/17/2014 for investigation.Investigation results as follows: the reported complaint of the platform displaying a 'system error - out of service' message was confirmed.Latched error 132 (internal watchdog timeout) was observed in the archive file as well as upon power on of the platform prior to functional testing.The error message was cleared to remedy the complaint.The reported issue of the upper and lower housing separating was also confirmed.Visual inspection found that the front bumper, encoder cover, motor cover and head restraint brackets were damaged and that the battery partition cover was missing.The damaged and missing components were replaced.Following service, the platform 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: 3598324
• MDR Text Key: 4192160
• Report Number: 3003793491-2014-00060
• 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: 01/13/2014

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 01/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2005
• 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