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

Model Number MODEL 100

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a shift check, it was observed that when lifebands were inserted into the autopulse® platform, they would not stay connected and would fall off from the bottom of the platform.When testing the same the lifebands on other platforms, they would stay attached.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Zoll circulation has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer 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 and the archive data shows that no clinical event with a patient occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue was reproduced.Inspection of the channel die cast confirmed that the lifeband would fall out.It was found that the machined channel was defective.In addition, the platform was run with the 95% patient test fixture with good batteries for several hours and no faults or errors were observed.Load cell characterization test was also performed which indicated that both load cell modules were functioning within specification.Based on the investigation, the part identified for replacement was the die cast channel.In summary, the reported complaint was confirmed during functional testing.Upon replacement of the die cast channel, the platform was re-evaluated 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: 3913724
• MDR Text Key: 4513971
• Report Number: 3003793491-2014-00319
• 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: 06/11/2014

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: 06/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2014
• Initial Date FDA Received: 07/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2011
• 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