MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (s/n (b)(4)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error messages" was confirmed during functional testing and based on the archive data review.The root cause of the reported ua45 error was the driveshaft not to be at "home" position, most likely attributed to unintended user error.The reported complaint of "the autopulse platform unexpectedly powered off multiple times" was confirmed during the archive data review.Several "time out" incidents were observed in the archive data files, indicating that the autopulse automatically powered off after the platform displayed the ua45 error messages.Visual inspection of the returned autopulse platform was performed and revealed that the front and bottom enclosures had multiple cracks at their screw well areas.The observed physical damages were unrelated to the reported complaints and were appeared to be the characteristics of harsh impact due to user mishandling.The damaged enclosures will be replaced to resolve the issues.Archive data review revealed that there were no device activity/compressions delivered from january 27, 2021, through the end of the archive (february 24, 2021).Based on the archive data review, multiple user advisory (ua) 45 error messages occurred during multiple power on/power off cycles from january 27, 2021, through february 24, 2021, and there were several "timeout" incidents that occurred during the mentioned time frame; thus, confirming the reported complaints.The "time out" state will occur with an automatic shut-off after 2 minutes if there was any user advisory error displayed.Further review of the archive data files showed several "battery lost" incidents from january 27, 2021, through february 24, 2021.The "battery lost" state will occur due to battery removal during active operation.Possibly, the customer pulled out the battery and re-inserted it back into the platform during their troubleshooting of the reported issues.User advisory is normally a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse® resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45) pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.During functional testing, a ua45 error message was displayed upon powering up the platform; thus, confirming the reported complaint.The driveshaft was rotated to "home" position to clear the ua45 error message.During further testing, the autopulse was subjected to a run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries.The autopulse platform repeatedly failed the functional testing and displayed user advisory (ua)17 (max motor on time exceeded during active operation) error messages, unrelated to the reported complaints.The root cause of the ua17 error was the defective drivetrain motor due to a defective component, and it will be replaced to remedy the fault.Awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

Event Description

The customer reported that the autopulse platform (s/n (b)(4)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error messages, and also it unexpectedly powered off multiple times during training sessions, device checks, and patient calls.When the reported issues happened during patient calls, the crew used a second autopulse platform as a backup.No consequences or impact to patients.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• 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: 11606699
• MDR Text Key: 244063265
• Report Number: 3010617000-2021-00286
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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: 03/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2018
• 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