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

Model Number MODEL 100

Device Problems Break (1069); Retraction Problem (1536)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2015

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse lifeband did not retract on the autopulse platform.No error messages were reportedly seen on the display.Customer also reported that both ends of the head restraint were damaged.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/09/2015 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 platform was performed.Both top cover wire strands were found to have been cut, thus confirming the reported complaint of the head restraint being damaged.The bottom and front covers were also found to have been cracked.From the condition of the platform, the physical damages appear to have been due to normal wear and tear.Functional testing was performed and the platform performed as intended with no user advisories or warnings exhibited.In addition, the reported issue of the lifeband not retracting as intended could not be reproduced.Load cell characterization was performed and found that load cell module 1 was not functioning normally with its output signals found to be fluctuating.Load cell module 1 was replaced to remedy this issue.Consistent with the reported information indicating no error messages occurred, the review of the platform's archive data showed no user advisories on the reported event date.However, there were multiple user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) codes found on other dates.The ua 7 codes found in the archive are attributed to the previously identified defective load cell module 1.Based on the investigation, the parts identified for replacement were the following: the top cover, front cover, and load cell module 1.In summary, the reported complaint of physical damage to the head restraint was confirmed and attributed to wear and tear.The issue of the lifeband not retracting as intended could not be reproduced.Functional testing showed the platform performed as intended.Unrelated to the reported complaint, the platform archive data review showed multiple ua 7 codes occurring on dates other than the event date.Load cell characterization identified the cause to be a defective load cell module 1.Following service, including replacement of the damaged parts and the load cell module, the device passed all testing criteria.

• 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: 4542117
• MDR Text Key: 17946625
• Report Number: 3010617000-2015-00124
• 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: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2015
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2007
• 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