MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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 04/03/2024

Event Type  malfunction  

Event Description

The customer reported the autopulse platform (b)(6) was brought in with blood in the head restraint wires that cannot be cleaned out.The head restraint wires are broken and frayed and need to be replaced.Also, the display screen on the board is dark and hard to read.However, the customer reported the board works fine.No patient involvement.

Manufacturer Narrative

The reported complaint that the autopulse platform (b)(6) was brought in with blood in the head restraint wires and the head restraint wires are broken and frayed was confirmed during the visual inspection.Both wire strands of the top cover were heavily frayed.The damaged head restraints do not render the autopulse platform non-functional.The likely root cause for the reported complaint was due to mishandling, however contribution from wear and tear cannot be ruled out due to the age of the device.The autopulse platform was manufactured in 2007 and is over 17 years old, well past its expected serviceable life of 5 years.The top cover will be replaced to address the reported complaint.The secondary complaint that the display screen on the autopulse platform (b)(6) is dark and hard to read was confirmed during the visual inspection.The root cause for the reported complaint was a failed lcd, likely attributed to the age of the device.The lcd will be replaced to remedy the issue.Upon further visual inspection, the bottom and front covers had multiple cracks in the screw well area and the load plate cover has noticeable cuts, unrelated to the reported complaint.The observed physical damages appeared to be the characteristics of user mishandling.The front, bottom, and load plate covers will be replaced to address the issue.Upon review of the archive data, no significant discrepancies were found.The autopulse platform passed the initial functional testing without any fault or error.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 autopulse platform with sn (b)(6).

Manufacturer Narrative

Service was not performed on the autopulse platform with serial number (b)(6).Due to the age of the device, and zoll proposed a newer platform as a replacement.The customer accepted the offer and their original device (sn (b)(6)) was scrapped at zoll.The new ap platform with serial number (b)(6), which was manufactured on june 22, 2022, was shipped to the customer.

• 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19177706
• MDR Text Key: 341285629
• Report Number: 3010617000-2024-00345
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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,Followup
• Report Date: 05/14/2024

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2007
• 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