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

Model Number MODEL 100

Device Problem Image Display Error/Artifact (1304)

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

Event Date 01/06/2014

Event Type  malfunction  

Event Description

It was reported that duirng a morning shift check, the autopulse platform displayed a user advisory 45 (not at "home" position after power-on/restart) message upon power on.Customer attempted to extend the lifeband and powered the platform on but the issue did not resolve.No patient involvement was reported.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/13/2014 for investigation.Investigation results as follows: the reported complaint of the platform displaying user advisory 45 (not at "home" position after power-on/restart) was confirmed.Review of the archive data does not show the fault occurring on the reported event date of (b)(6) 2014; however the fault was observed to have occurred on (b)(6) 2014.The investigation results indicated that the cause of the ua 45 fault was the driveshaft being out of its home position.The driveshaft was rotated back to its home position.Following service, the device passed all testing criteria.Please note that per the autopulse user guide, a user advisory generally indicates that a misalignment or inappropriate movement of the patient or the lifeband has occurred.This condition is typically correctable by the operator.The autopulse driveshaft has a "home" position that is a point of reference for autopulse operation.If the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.

• 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: 3594454
• MDR Text Key: 4093554
• Report Number: 3003793491-2014-00051
• 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: Invalid Data
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/07/2014

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: 01/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2014
• Initial Date FDA Received: 01/28/2014
• 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