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 12/09/2022

Event Type  malfunction  

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 both archive data review and functional testing.The root cause of the ua07 was due to failed load cell # 2.The cracked front cover and load cell failure were likely attributed to mishandling such as a drop.During visual inspection, the front enclosure was observed damaged with a vertical crack going through one of its screw fittings, unrelated to the reported complaint.This observed physical damage appeared to be the characteristic of harsh impacts due to user mishandling.The front enclosure was replaced to address the issue.During further inspection, 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.A review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) advisory messages, confirming the reported complaint.Functional testing failed due to the ua07 advisory message displayed upon powering up the platform, confirming the reported complaint.Technical investigation revealed that load cell # 2 failed to function within the specification, which caused the ua07 advisory messages.The failed load cell #2 was replaced 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.Following service, a 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 complaint reported for autopulse platform with serial number (b)(4).

Event Description

During shift check, the autopulse platform (sn (b)(4) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).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: 16076283
• MDR Text Key: 306436411
• Report Number: 3010617000-2022-02109
• 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: 12/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2021
• 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