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

Model Number MODEL 100

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse platform goes through batteries very quickly.No specific details were provided and no patient involvement was reported.Customer also reported that during a shift check, the platform's head restraint was damaged and the load plate screws were missing.Manufacturer has requested additional information from the customer; however, no additional information has been obtained.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(4) 2014 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 shows that the battery lock clip was bent and the top cover was damaged.It was also observed that the load plate screw was missing.The physical damages found during visual inspection confirmed the reported event of the damaged head restraint and missing load plate screw.The damages appear to have been caused by normal wear and tear (autopulse manufactured in july of 2007).A review of the autopulse archive was performed and shows that no sessions occurred on the reported event date of (b)(6) 2014.A review of the autopulse archive was performed to assess the customer's battery management practices.Review of the archive shows that the batteries were not properly maintained.In addition, the archive shows that (b)(6) 2014, warning 1 ("low battery" warning) and user advisory (ua) 17 (max motor on time exceeded during active operation) faults occurred with li-ion batteries with serial numbers (s/n's) (b)(4).Per the autopulse maintenance guide (p/n 11653-001), ua 17 typically occurs when the lifeband is twisted or the battery voltage is low.The root cause of the ua 17 was determined to be the use of low voltage batteries (s/n (b)(4)).The system is expected to show a "low battery" warning when fault 17 has been triggered.An investigation conducted using the li-ion batteries' serial numbers found that the batteries were within its expected lifetime.The batteries were also test cycled appropriately.Functional testing was performed and the reported issue that the platform goes through batteries very quickly was not confirmed.The platform ran for 60 minutes using a large resuscitation test fixture (lrtf) with no problems.However, a ua 11 (max patient temperature exceeded) fault was observed during testing.The temperature sensor cable was found to be at fault.Based on the investigation, the parts identified for replacement were the top cover, missing load plate screw, battery lock clip and the temperature sensor cable.In summary, the reported complaint that the platform goes through batteries very quickly was confirmed based on the battery management assessment on (b)(6) 2014.The fault was found to be due to batteries that were not fully charged at the time that they were used in the autopulse platform.The reported complaint of the damaged head restraint and the missing load plate screw was confirmed during visual inspection.The faults were found to be due to normal wear and tear.The observed ua 11 that occurred during functional testing is unrelated to the reported complaint.Upon replacement of all parts, the platform was re-evaluated through functional testing and 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: 4082526
• MDR Text Key: 18921409
• Report Number: 3010617000-2014-00457
• 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: 08/21/2014

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: 09/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2014
• Initial Date FDA Received: 09/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2007
• 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