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

Model Number MODEL 100

Device Problems Break (1069); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

It was reported that during a morning shift check, the autopulse platform displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message that was unable to be cleared.Customer also reported that one of the head restraints was broken.No patient involvement 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 was returned to zoll on 11/21/2014 for investigation.Investigation results as follows: visual inspection of the returned platform showed that the load plate cover was torn, two shoulder screws were missing and the top cover wire strands were cut.The physical damages found during visual inspection confirmed the reported complaint that one of the head restraints was broken.However, the visual inspection results are not related to the reported complaint of a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) fault that did not clear.The damages appear to have been caused by normal wear and tear (autopulse manufactured in 08/2007).A review of the autopulse platform's archive was performed and did not confirm the reported complaint.The archive data shows no sessions to have occurred on the reported event date of (b)(6) 2014.Upon powering on the platform, a ua 7 fault was observed.Functional testing could not be performed due to the ua 7.Furthermore, a load cell characterization test was performed and indicated that load cell module 1 was not functioning properly.It was determined that load cell module 1 was at fault.Based on the investigation, the parts identified for replacement were the top cover, load plate cover, load cell module 1 and both shoulder screws.In summary, the reported complaint of a ua 7 fault was confirmed upon functional testing.The fault was found to be due to the defective load cell module 1.The reported complaint of a broken head restraint was confirmed during visual inspection.The fault was found to be due to normal wear and tear.Upon replacement of all parts, the platform was re-evaluated through functional testing and 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: 4246442
• MDR Text Key: 18032061
• Report Number: 3010617000-2014-00602
• 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: 10/23/2014

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2007
• 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