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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

During shift check, the customer noted that the lcd screen of the autopulse platform (s/n (b)(4) was dark.No further information was provided.No patient involvement.

Manufacturer Narrative

The reported complaint that "the lcd screen of the autopulse platform (s/n (b)(4) was dark" was confirmed during functional testing.The root cause of the reported complaint was the defective processor board, attributed to a defective component.Visual inspection of the returned autopulse platform revealed no physical damage.During further inspection, it was noted that the encoder driveshaft was stiff and did not rotate smoothly, unrelated to the reported complaint.The root cause was due to the sticky driveshaft clutch area, which 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.The archive data review showed no significant discrepancies.The autopulse platform passed the initial functional test and powered on without any fault or error.The zoll service personnel noted that the lcd screen was dark, confirming the reported complaint.The backlight of the display was not functional, and the lcd screen was only readable in the presence of light.Troubleshooting the problem revealed that the processor board was defective, and it was replaced to remedy the issue.The autopulse platform passed all subsequent functional tests without any fault or error.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.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 similar complaint reported for autopulse 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: 15126448
• MDR Text Key: 297578125
• Report Number: 3010617000-2022-00910
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2022

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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