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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

The reported complaint was confirmed during archive review but not during initial functional testing.The root cause for the platform stop compressing was caused by error message user advisory (ua) 17 (max motor on time exceeded) due to the drive shaft not reaching the target depth within specification due to the medium/large size stiff to compress patient.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.User advisory error messages are designed into the platform when one of several conditions is detected.Ua 17 alerts the user that the drive motor did not reach the target depth within specification when used on a medium/large size stiff patient and when the battery being used has a low voltage.No physical damage was noted during visual inspection.The encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The archive data review indicated error message ua 17 on (b)(6) 2017 but not on (b)(6) 2017.Based on the archive, the li-ion battery with serial number (b)(4) was used and the platform performed 2046 compressions on a large stiff patient.The platform stopped performing compression due to error message ua 17.The user pressed restart to clear the fault and a different li-ion battery with serial number (b)(4) was used.The platform then performed 102 compression on the same large stiff patient before stopped compression with ua 17 and low battery warning error message.The platform passed the initial functional testing without any issues.No brake activation was noted when the unit was powered on due to the drive train motor brake gap being out of specification.Brake gap adjustment was performed and run-in test was performed using large resuscitation test fixture (lrtf) with known good batteries until discharged without any issues.An additional repair and update was completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue.The clutch plate deburring was performed; after which the platform passed all the final functional testing.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints for autopulse sn (b)(4).

Event Description

During shift check, the autopulse platform (sn: (b)(4)) stopped working after performing compression for 30 minutes.No patient was involved.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7179723
• MDR Text Key: 96963229
• Report Number: 3010617000-2018-00014
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/10/2018

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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2005
• 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