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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Device Contamination with Body Fluid (2317)

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

Event Date 04/15/2015

Event Type  malfunction  

Event Description

It was reported that the autopulse platform was full of blood and did not power on.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 04/17/2015 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 external and internal blood contamination.The platform underwent biohazard cleaning to remedy the blood contamination.During functional testing, the platform displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message.Load cell characterization testing was performed and confirmed that one of the load cells was defective.A review of the platform's archive data found that no faults or errors occurred on the reported event date of (b)(6) 2015.Based on the investigation, the part identified for replacement was the load cell.The platform underwent and passed all final functional testing.In summary, the customer's reported complaint that the platform did not power on was not confirmed as the platform powered on with no issues when received at zoll (b)(4).Visual inspection of the platform did find external and internal blood contamination.The platform underwent biohazard cleaning to remedy the contamination.During functional evaluation, the platform displayed a ua 7 message.The root cause of the ua 7 message was determined to be a defective load cell.It should be noted that the ua 7 message is unrelated to the reported complaint.After replacement of the load cell, the platform underwent and passed all final functional testing.

• 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: 4759885
• MDR Text Key: 5796026
• Report Number: 3010617000-2015-00271
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2008
• 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