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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 12/22/2014

Event Type  malfunction  

Event Description

It was reported that the autopulse platform displayed fault 17 (max motor on time exceeded during active operation) and fault 20 (position out of range) messages.Customer indicated that fully charged autopulse nimh and li-ion batteries were used.In addition, when the "continue" button was pressed, the motor did not work.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 02/27/2015 for investigation.Investigation results as follows: visual inspection was performed and no damages were observed.The returned platform displayed a fault 26 (decompression target not reached) during power on.No further functional evaluation could be performed due to this fault.Further inspection identified the cause to be the drivetrain motor, which was not functioning properly.After replacing the drivetrain motor, the platform was functionally tested and the reported user advisory (ua) 17 (max motor on time exceeded during active operation) and ua 20 (position out of range) codes could not be duplicated.The platform passed all functional test requirements.A review of the platform's archive data was performed and found that there were no user advisories (ua's) on the reported event date of (b)(6) 2014.Furthermore, there were no ua 20 codes seen throughout the entire available archive.The last occurrence of a ua 17 code was seen on (b)(6) 2014.The cause of the ua 17 is likely due to the previously noted drivetrain motor not functioning properly.Unrelated to the reported complaint, multiple ua 16 (timeout moving to take-up position) and ua 23 (compression will exceed 3 revolutions) codes were seen on (b)(6) 2014.The cause of the ua 16 was due to the previously noted defective drivetrain motor and the cause of the ua 23 was likely due to the customer not fully extending the lifeband (by pulling the straps completely out of the channel).Based on the investigation, the part identified for replacement was the drivetrain motor.In summary, the reported complaint of the platform displaying a ua 17 was confirmed based on platform archive review.Although no ua 17 codes were seen on or around the reported event date, an occurrence was seen on (b)(6) 2014.The cause was determined to be a defective drivetrain motor.The reported ua 20 could not be confirmed through archive review or functional evaluation.Following service, including replacement of the drivetrain motor, the platform passed all functional test 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: 4517457
• MDR Text Key: 5488251
• Report Number: 3010617000-2015-00095
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2015
• Initial Date FDA Received: 02/13/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2013
• 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