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

Model Number MODEL 100

Device Problems Material Separation (1562); Component Missing (2306)

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

Event Date 03/27/2014

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform performed only 1 compression with a mannequin before releasing and stopping.Customer stated that good, known, working (i.E.Fully charged) autopulse li-ion batteries were used.It was also reported that the right hand side of the platform separated and the top side pin was missing.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The product in complaint was returned to zoll on (b)(6) 2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform shows that the top cover, encoder cover, and the battery compartment were damaged.In addition, the battery partition cover and the patient restraint pin were missing.The physical damages found during visual inspection confirmed the reported issue of the separated right hand side of the platform and the missing top side pin.The damages appear to have been caused by normal wear and tear (autopulse manufactured in august of 2005).Review of the archive was performed and the reported complaint of the platform stopping compressions was confirmed.The archive data shows that no sessions occurred on the reported event date of (b)(6) 2014.However, the archive shows that user advisory (ua) 2 (compression tracking error) and ua 18 (max take-up revolutions exceeded) occurred on (b)(6) 2014.Functional testing could not be performed due to defective load cells.The load cell count for each cell was hardly increasing with additional weight placed on the platform.Based on investigation, the parts identified for replacement are the top cover, encoder cover, battery compartment, battery partition cover, and the load cells.In summary, the reported complaint of the platform stopped compression was confirmed based on the archive review and during functional testing.The faults were found to be due to the defective load cells.The reported issue of the separated right hand side of the platform and the missing top side pin was confirmed during visual inspection.Upon replacement of the load cells and the damaged parts, 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: 3760194
• MDR Text Key: 4419949
• Report Number: 3003793491-2014-00197
• 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: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2014
• 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: 04/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2005
• 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