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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that "the autopulse platform sn (b)(4) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) multiple times" was confirmed in the platform's archive data and during functional testing, performed at zoll.The root cause of the ua45 advisory message was that the driveshaft was not in "home" position, most likely attributed to unintended user error.During visual inspection, the front and bottom enclosures as well as the top cover were observed damaged, unrelated to the reported complaint.Based on the photos provided by the zoll service team, the top and bottom enclosures had multiple broken screw bosses.There was a long crack on the top cover.Cracks and breakages were also observed in the interior of the top cover.These physical damages are the characteristic of harsh impacts due to user mishandling.All the covers were replaced to address the issues.The archive data review indicated multiple ua45 advisory messages on the customer's reported event date and previous dates, confirming their complaint.Further review of the archive data indicated multiple ua20 (position out of range) advisory messages occurred around the customer's reported event date, unrelated to the reported complaint.Based on the archive data files, the user was able to clear the ua20 error codes.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.Per autopulse user advisory list guide, user advisory (ua) 20 occurs due to the encoder driveshaft not being within the normally acceptable range of positions.Typically, if the user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) is not resolved properly, it leads to ua20 because the driveshaft is not restored at its "home" position.To clear a ua20, return the driveshaft to its "home" position using the platform's administrative menu.The autopulse platform failed initial functional testing due to a ua45 advisory message displayed upon powering up, confirming the reported complaint.The zoll service personnel rotated the platform's driveshaft to "home" position to remedy the fault.Subsequently, the autopulse platform was subjected to a run-in test using the large resuscitation test fixture (lrtf) for 15 minutes, the platform passed the test without any fault or error.During device evaluation and service, the platform's drivetrain motor brake gap was inspected, cleaned, and verified that the brake gap was within the specification.Following service, the autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.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

During a shift check, the autopulse platform sn (b)(4) displayed user advisory (ua) 45 (not at "home" position after power-on/restart).The customer followed zoll user guide instructions to clear the ua45.They pulled up the lifeband until the chest bands were fully extended and then restarted the platform.The customer turned the platform off/on multiple times, but the ua45 persisted.The customer exchanged the battery, replaced the lifeband multiple times, and attempted to pull it up and fully extend the chest bands again.But ua45 did not clear.Zoll tech support sent the customer step-by-step directions on how to reset the driveshaft.The customer forwarded the directions to their ems coordinator, and he stated that the ua45 has happened multiple times this year, and they have used several lifebands to reset the driveshaft to clear the advisory message.The customer requested this autopulse platform to be evaluated by zoll as it has shown the ua45 advisory message multiple times.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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16076275
• MDR Text Key: 306499080
• Report Number: 3010617000-2022-02099
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2022

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: 12/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• 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