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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281); Noise, Audible (3273)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that auto pulse platform sn (b)(6) displayed fault code 16 (timeout moving to take-up position) was confirmed during archive data review and functional testing.The reported complaint that the customer could hear the motor was trying to rotate, but it would not was confirmed during functional testing.The root cause for both complaints was a seized integrated encoder gearbox, likely attributed to a failed component or wear and tear.The auto pulse platform was manufactured in 2018 and is 6 years old, past its expected service life of 5 years.The customer complaint that the life band was very difficult to pull up was confirmed during visual inspection.A very sticky drive shaft clutch area was observed.This caused difficulty for the user to pull up the life band completely.The sticky clutch area is usually caused by sharp edges from all 12-hex edges of the armature plate, or due to burrs on the clutch rotor's surface, likely attributed to normal wear and tear.The clutch plate will be deburred to remedy the complaint.During visual inspection, unrelated to the reported complaint, a cracked front enclosure was observed.The probable root cause for the observed physical damage was user mishandling.The front enclosure will be replaced to address the damage.The archive data indicated fault code 16; thus, confirming the customer's reported complaint.The auto pulse platform failed the initial functional testing due to the fault code 16 displayed before the first compression, confirming the reported complaint.The integrated encoder gearbox will be replaced to address the observed failure.Upon service completion, the platform will be subjected to final functional testing to ensure that the device passes all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for auto pulse platform with serial number (b)(6).

Event Description

During an on-site visit, a zoll representative observed that autopulse platform sn (b)(6))displayed an error message stating align patient.He believes the platform displayed fault code 16 (timeout moving to take-up position).The platform says to pull up the lifeband but the lifeband was very difficult to pull up.He noticed that he could hear the motor was trying to rotate, but it would not.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18735831
• MDR Text Key: 335942565
• Report Number: 3010617000-2024-00158
• 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: 02/19/2024

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: 02/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• 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