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

Model Number MODEL 100

Device Problems Break (1069); Component Missing (2306); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform displayed multiple user advisory (ua) messages.In addition, the load plate screws were missing and the head restraint was damaged.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 load plate screws (shoulder screws) were missing.The head restraint wire, front enclosure, battery lock and battery compartment were damaged.The lcd display was missing pixels (only half of the display was visible).Based on the condition of the returned platform, the observed damages were due to wear and tear.A user advisory (ua) 45 (not at "home" position after power-on/restart) message was observed during power on of the platform.Further inspection determined that the driveshaft was out of its home position causing the observed ua 45.A review of the archive was performed and multiple ua 45 messages were noted to have occurred on (b)(6) 2014.It should be noted that no ua faults occurred on the reported event date of (b)(6) 2014.Based on the investigation, the part(s) identified for replacement were the shoulder screws, top cover, lcd display, front enclosure, battery lock, and battery compartment.In summary, the reported complaints of the load plate screws missing and head restraint being damaged were confirmed during visual inspection and attributed to wear and tear.The reported issue of multiple ua faults occurring with the platform was also confirmed during functional testing as well as archive review.The platform powered on with a ua 45 fault and archive data further determined multiple ua 45 faults had occurred on (b)(6) 2014.The ua 45 faults were found to be due to the driveshaft having shifted out of its home position.Following re-positioning of the driveshaft and replacement of the damaged and missing parts, the device 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: 3911275
• MDR Text Key: 4668100
• Report Number: 3003793491-2014-00317
• 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: 06/10/2014

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: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 07/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2007
• 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