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

Model Number MODEL 100

Device Problems Break (1069); Device Displays Incorrect Message (2591)

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

Event Date 01/02/2015

Event Type  malfunction  

Event Description

It was reported that the autopulse platform displayed a user advisory (ua) 18 (max take-up revolutions exceeded) message.Customer also reported that the head restraints were damaged.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 01/20/2015 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 returned platform was performed and found that the wire loops on the top cover were damaged and both the front and bottom covers were cracked.None of these parts effect the functionality of the platform.The physical damages found during visual inspection confirmed the customer's reported complaint of damaged head restraints.The system was turned on/off with no problems and ran using a 95% patient test fixture for several hours with no anomalies or errors exhibited.A review of the platform's archive was performed and found no errors or anomalies on the reported event date of (b)(6) 2015; however, user advisory (ua) 18 (max take-up revolutions exceeded) error codes were noted to have occurred on (b)(6) 2014, the last record of customer usage in the archive.No parts were replaced to remedy the customer's reported complaint of the platform exhibiting a ua 18.All parts which were noted to be damaged during the visual inspection of the platform were replaced.The platform underwent and passed all final functional testing.The customer's reported complaint of the platform exhibiting a ua 18 was confirmed through review of the platform's archive.The root cause of the exhibited ua 18 was determined to be have been due to no significant load being placed on the platform.At the time that the ua 18 occurred, the archive showed that there was no change in the load.The autopulse® was designed to exhibit ua 18 to prevent patient harm.

• 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: 4485202
• MDR Text Key: 20064439
• Report Number: 3010617000-2015-00078
• 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: 01/13/2015

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 02/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2007
• 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