MAUDE Adverse Event Report: ZOLL CIRCULATION ELECTRIC CARDIAC RESUSCITATOR; 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 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

During preventative maintenance (pm) of the autopulse platform (s/n (b)(4)), the zoll service personnel found that the lcd screen was dark/unreadable.The root cause of the observed issue was the defective processor board, likely due to the age of the device, wear and tear.The autopulse platform was manufactured in january 2011 and is over 10 years old, well beyond its expected service life of 5 years.During visual inspection, the front enclosure was observed cracked, unrelated to the noted lcd screen issue.The observed physical damage is likely attributed to user mishandling/neglect.There is no documented report showing that annual preventative maintenance (pm) was performed by zoll since the device was acquired by the customer in 2011.The front enclosure was replaced to address the issue.The autopulse platform was further examined, and it was noted that the power distribution board revision level was below 6, attributed to the age of the platform and unrelated to the noted lcd screen issue.The power distribution board was replaced to address the problem.The autopulse platform passed the initial functional test without any fault or error.A load cell characterization test was performed and verified that both load cells were functioning within the specification.During functional testing, the zoll service personnel noted that the backlight of the display flickered briefly when the platform was powered on, and it went dark afterward.Troubleshooting the problem determined that the processor board was defective, causing the lcd backlight issue.The defective processor board was replaced to remedy the fault.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform was subjected to a 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 autopulse platform with serial number (b)(4).

Event Description

During preventative maintenance (pm) of the autopulse platform (s/n (b)(4)), the lcd screen was dark/unreadable.No patient involvement.

• Brand Name: ELECTRIC CARDIAC RESUSCITATOR
• 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: 13581999
• MDR Text Key: 286232339
• Report Number: 3010617000-2022-00183
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: D163369
• 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: 02/22/2022

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: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2011
• 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