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

Model Number MODEL 100

Device Problem Sticking (1597)

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

Event Date 05/29/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a device check when the start/continue button was pressed, the driveshaft would not rotate to allow the lifeband® to perform take-up.Even though complainant attempted to reinstall and pull the lifeband® up completely, the issue still persisted.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Product in complaint was initially received by zoll (b)(4).Zoll (b)(4) was able to confirm the customer's reported complaint.In addition zoll (b)(4) also observed a user advisory 16 (timeout moving to take-up position) on the autopulse® display.Investigation is still in progress.A supplemental report will be filed once the investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll japan for analysis.Visual inspection of the returned platform shows no visible or physical damage to the platform.A review of the autopulse archive was performed at zoll (b)(4) and the reported complaint was confirmed.The archive data shows that user advisory (ua) 16 (timeout moving to take-up position) occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue was reproduced.In addition, the ua16 fault was observed on the display.It was observed that the brake gap was out of specification.The brake gap was adjusted and the platform passed testing.Based on the investigation, no parts were identified for replacement.In summary, the reported complaint was confirmed based on the archive review and during functional testing.The fault was found to be due to the brake gap being out of specification.Upon adjusting the brake gap within specification, the platform was re-evaluated through functional testing and 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: 3885111
• MDR Text Key: 4543234
• Report Number: 3003793491-2014-00293
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2014

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 06/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2010
• 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