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 Contamination with Body Fluid (2317)

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

Event Date 06/13/2014

Event Type  malfunction  

Event Description

It was reported that during a patient event, the autopulse platform did not work at all when the crew put the patient onto the platform.Customer also reported that a large amount of blood got into the unit.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/20/2015 for investigation.Investigation results as follows: visual inspection was performed and the following was observed: the top cover was cracked and the battery connector was damaged.From the condition of the returned unit, the cause of the damages appear to have been wear and tear.The platform was powered on and a constant user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) was displayed.No further operation of the platform was possible due to the ua 7 code, thus confirming the complaint.Load cell characterization was performed and identified that load cell module 1 was under-reporting.Following replacement of the load cell module, the platform passed functional testing.A review of the platform's archive showed that on the reported event date of (b)(6) 2014, a ua 7 code as well as two ua 2 codes (compression tracking error) occurred.The cause for both codes was identified to be load cell module 1 not functioning properly.Based on the investigation, the part(s) identified for replacement were the top cover, battery connector and load cell module 1.In summary, the reported complaint was confirmed upon functional testing and during platform archive review.The platform displayed a constant ua 7 upon power on and, as a result, was non-functional.Evaluation of the platform identified the cause of the ua 7 to be load cell module 1 not functioning properly.In addition to the ua 7, two ua 2 codes were seen in the archive to have occurred on the reported event date.The cause for the ua 2 codes was also determined to be load cell module 1 under-reporting.Following service, including replacement of the damaged parts and load cell module 1, the device 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: 3929791
• MDR Text Key: 4671179
• Report Number: 3003793491-2014-00333
• 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: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• 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: 01/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2005
• 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
• Patient Age: 71 YR