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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

During preventative maintenance (pm), the autopulse platform (b)(6) failed functional testing with fault code 41 (patient temperature sensor failure).The root cause of fault code 41 was the malfunctioning temperature sensor, likely due to the age of the device.The autopulse platform was manufactured in march 2016 and is over 8 years old, well beyond its expected service life of 5 years.The malfunctioning temperature sensor was replaced to remedy the fault.During further inspection, it was noted that the encoder driveshaft was stiff and did not rotate smoothly, unrelated to the noted fault code 41.The likely root cause of this issue was related to the age of the device and non-usage of the platform for an extended period of time.Based on the archive data, the last time that the platform was powered on was in march 2023.Deburring of the clutch plate didn't resolve the stiff rotation of the driveshaft; therefore, the clutch plate was replaced to remedy the problem.Upon visual inspection, the front enclosure was observed cracked with a vertical crack going through one of its chipped screw fittings, unrelated to the noted fault code 41.The likely root cause of this physical damage is user mishandling, such as a drop.The front enclosure was previously replaced during service at zoll in august 2020.To address the current physical damage, the front enclosure was replaced.Additionally, the lcd screen backlight was flickering, unrelated to the noted fault code 41 and possibly due to the age of the platform.The lcd's backlight cable was inspected and re-seated, and the issue was resolved.During further inspection, it was also noted that there was no brake activation when powering up the platform, unrelated to the noted fault code 41.This issue was caused by the seized drivetrain motor brake assembly, likely related to the age of the device and non-usage of the platform for an extended period of time.The drivetrain motor brake assembly was cleaned and re-adjusted to resolve the issue.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 run-in test(s) using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with serial number (b)(6).

Event Description

During preventative maintenance (pm), the autopulse platform (b)(6) failed functional testing with fault code 41 (patient temperature sensor failure).Also, the platform's driveshaft was stiff.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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19149597
• MDR Text Key: 341284881
• Report Number: 3010617000-2024-00330
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• 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: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• 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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2016
• 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