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 12/05/2022

Event Type  malfunction  

Event Description

During a shift check, the autopulse platform (sn (b)(4) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).The customer was unable to clear the advisory message.No patient involvement.

Manufacturer Narrative

The reported complaint that "the autopulse platform (sn (b)(4) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large)" was confirmed during archive data review and functional load cell characterization test, performed at zoll.The root cause of the reported complaint was failed load cells.The cracked cover and the two failed load cells were likely attributed to mishandling such as a drop.During visual inspection, the front enclosure was observed damaged, unrelated to the reported complaint.Based on the photo provided by the zoll service team, a vertical crack and breakage were going through one of the screw fittings.The observed physical damage was most likely attributed to user mishandling such as a drop.The damaged front enclosure was replaced to address the issue.A review of the archive data showed a couple of user advisory (ua) 07 (discrepancy between load 1 and load 2 too large), confirming the reported complaint.The archive data showed that the ua07 was cleared, but the platform continuously displayed multiple ua45 (not at "home" position after power-on/restart) occurred on various dates, unrelated to the reported complaint.The ua45 was never cleared until the device was received at zoll.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.The autopulse platform failed initial functional testing due to a ua45 advisory message displayed upon powering up, unrelated to the reported complaint.The root cause of the reported ua45 advisory message was that the driveshaft was not in "home" position, most likely attributed to unintended user error.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 95% large resuscitation test fixture (lrtf) for 15 minutes, the platform passed the test, and the reported ua07 was not replicated.However, during further testing, the load cell characterization test failed and revealed that both load cells failed.This confirmed the root cause of the reported complaint of ua07, which happened intermittently.The load cells were replaced to resolve the problem.During further testing, it was noticed that the clutch plate was sticky, unrelated to the reported complaint.This is usually caused by sharp edges of the armature plate, or due to burrs on the surface of the clutch rotor.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.Following service, another load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.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 complaints reported for the autopulse platform with serial number (b)(4).

• 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: 16065453
• MDR Text Key: 306327647
• Report Number: 3010617000-2022-02096
• 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: 12/28/2022

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: 12/15/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2020
• 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