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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 06/18/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse platform displayed a user advisory 45 (not at "home" position after power-on/restart) message.Customer also indicated that the lifeband was not working.No adverse patient sequelae 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 of the returned platform shows that the top cover and the front enclosure were cracked and the battery lock was bent.The physical damages found during visual inspection are not related to the reported event of the platform showing a user advisory (ua) 45 (not at "home" position after power-on/restart) message.The damages appear to have been caused by normal wear and tear (autopulse manufactured in february of 2008).A review of the archive was performed and the reported complaint of the platform showing a ua 45 message was confirmed.The archive data shows that multiple ua 45 messages occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue of a ua 45 message was confirmed.Upon power up of the platform, the ua 45 message was observed.It was found that the driveshaft was not at the "home" position, which caused the lifeband to not work as intended.The driveshaft was rotated back to the "home" position and the platform ran for 7 minutes with no problems observed.Based on the initial investigation, the parts identified for replacement were the top cover, front enclosure and the battery lock.In summary, the reported complaint of a ua 45 message was confirmed based on the archive review and upon functional testing.Additionally, the customer's reported complaint that the lifeband was not working was also confirmed during functional testing.The faults were found to be due to the driveshaft not being at the "home" position.The physical damages found during visual inspection are unrelated to the reported complaint.

• 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: 3956351
• MDR Text Key: 19092470
• Report Number: 3003793491-2014-00372
• 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: 07/02/2014

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: 07/09/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2008
• 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