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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Complete Loss of Power (4015)

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

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4) displayed a user advisory "(ua)17" (max motor on time exceeded during active operation) error message" was confirmed during functional test and archive data review.The root cause of the ua17 advisory message was due to the drivetrain motor brake does not engage when the autopulse platform was powered on, which is likely attributed to the age of the device.The platform was manufactured in august 2016, and is 6 years old, past its expected service life of 5 years.The secondary reported complaint of the autopulse platform shut down and does not power on was not confirmed during functional testing.The autopulse platform powered on and did not shut down during preliminary and final functional testing.During visual inspection, unrelated to the reported complaint, noted cracked inside the screw holder area of the front enclosure and the load plate cover defected with the hole that affects the watertight seal was observed, likely due to mishandling such as a drop.The front enclosure and the load plate cover were replaced to address the observed physical damaged issues.The archive data review indicated multiple ua17 error messages were recorded around the reported event date, thus confirming the reported complaint.Also, in the archived, multiple fault code 16 (timeout moving to take-up position) occured around the reported event date, unrelated to the reported complaint.The root cause of ua17 and fault code 16 was the drivetrain motor brake does not engage.The autopulse platform failed initial functional testing due to the drivetrain motor brake does not engage when the autopulse platform was powered on which caused the ua17 error message.Thus, confirming the reported complaint.To remedy ua 17 error, the brake screws were untightened.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse platform passed the final testing 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 testing on a manikin, the autopulse platform (sn (b)(4) stopped compression for about 2 seconds and then the lifeband slowly released and then a user advisory "(ua)17" (max motor on time exceeded during active operation) error message displayed on the screen.After restarting the autopulse platform, compression on the manikin resume.Afterwards, a clack noise was heard and shortly afterwards, the display went dark, and the autopulse platform shut down and could not be powered on again.The autopulse platform powered on after removing the autopulse li-ion battery and reinserting it back.No patient involvement.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(6)) stopped compression for about 2 seconds and then the lifeband slowly released and then a user advisory "(ua)17" (max motor on time exceeded during active operation) error message displayed on the screen" was confirmed during functional test and archive data review.The root cause of the autopulse platform to stop compressions and slowly releasing lifeband was due to ua17 message.The root cause of the ua17 advisory message was drivetrain motor brake failed to engage due to the loose screws on the brake, which is likely attributed to the overtime use.The platform was manufactured in august 2016, and is 6 years old, past its expected service life of 5 years.During visual inspection, unrelated to the reported complaint, noted cracked inside the screw holder area of the front enclosure and the load plate cover was damaged with the hole that affects the watertight seal, likely due to mishandling such as a drop.The front enclosure and the load plate cover were replaced to address the observed physical damages.The archive data review indicated multiple ua17 error messages around the reported event date, thus confirming the reported complaint.Also, further review of the archive indicated, multiple fault code 16 (timeout moving to take-up position) around the reported event date, unrelated to the reported complaint.The root cause of ua17 and fault code 16 was the drivetrain motor brake does not engage due to loose screws on the brake.The autopulse platform failed initial functional testing due to the drivetrain motor brake does not engage when the autopulse platform was powered on which caused the ua17 error message.Thus, confirming the reported complaint.To remedy ua 17 error, the brake screws were tightened.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse platform passed the final testing 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)(6).

• 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: 15629160
• MDR Text Key: 304883145
• Report Number: 3010617000-2022-01844
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 02/10/2023

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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