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

Model Number MODEL 100

Device Problems Device Slipped (1584); Device Displays Incorrect Message (2591)

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

Event Date 01/02/2015

Event Type  malfunction  

Event Description

It was reported that the autopulse platform displayed a user advisory (ua) 12 (lifeband not present) message.Customer indicated that the platform is not holding the autopulse lifeband in.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/20/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform was performed and found no physical damages to the platform.The platform failed initial functional testing as it exhibited a user advisory (ua)12 (lifeband not present) when it was powered on.A review of the platform's archive was performed and found no errors or anomalies on the reported event date of (b)(6) 2015; however, multiple ua 12 error codes were noted to have occurred on (b)(4) 2014.The washer spring in the driveshaft slot was replaced to remedy the customer's reported complaint of the platform exhibiting ua 12.The platform underwent and passed all final functional testing.In summary, the customer's reported complaint of the platform exhibiting a ua 12 message was confirmed through review of the platform's archive and upon initial functional testing.The root cause of the platform exhibiting the ua 12 was determined to be a worn out washer spring in the driveshaft slot, which did not allow the lifeband to lock into place.The washer spring in the driveshaft slot was replaced, allowing the lifeband to lock into place and the platform to function as intended.The autopulse® was designed to exhibit ua 12 to prevent patient harm.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4485101
• MDR Text Key: 5331039
• Report Number: 3010617000-2015-00077
• 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,Followup
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• 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: 01/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2007
• 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