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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse displayed ua45 (not at "home" position after power-on/restart) error message was confirmed during the functional testing and in review of the archive data.The driveshaft was rotated back to home position to remedy the issue.The likely root cause of the issue was due to user error.Per the autopulse user guide instruction, to clear ua 45, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.The user advisory will persist until the driveshaft is returned to its home position.Visual inspection was performed and found the front enclosure was damaged, front cover's head restraint wire loop were cut and heavily frayed and encoder drive shaft does not rotate smoothly, exhibits binding and resistance, unrelated to the reported complaint.The front enclosure and top cover were replaced and the sticky clutch plate was deburred to remedy the damaged found during visual inspection.The autopulse platform is a reusable device and was manufactured in 2007 and is 11 years old.It has exceeded its expected service life of 5 years.This type of physical damage found during visual inspection is characteristic of normal wear and tear for the age of the device.The autopulse underwent functional testing with a large mannequin fixture (equivalent to 250 pounds patient) for 15 minutes.The platform passed functional testing with no fault.Archive review showed ua45 (not at "home" position after power-on/restart) error message occurred on the reported event date of (b)(6) 2018 thus confirming the reported complaint.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse with serial number (b)(4).Ccr (b)(4), reported on (b)(6) 2015, the drive shaft was rotated by user back to "home" position to remedy the issue.

Event Description

During shift check, the autopulse platform ((b)(4)) displayed a user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message.Customer reported that the drive shaft could not be turned manually.No patient involvement.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 7528082
• MDR Text Key: 108732668
• Report Number: 3010617000-2018-00559
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2007
• 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