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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2023

Event Type  malfunction  

Event Description

The customer reported the autopulse platform (sn 33887r) consistently displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

Manufacturer Narrative

Zoll has not yet received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn (b)(6) consistently displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message was confirmed during functional testing and review of the archive data.The root cause of the (ua)07 was due to failed load cell #1.The cracked cover and load cell failure were likely attributed to mishandling such as a drop, or the age of the platform.The autopulse platform was manufactured in 2017 and is over 7 years old, past its expected service life of 5 years.During visual inspection, unrelated to the reported complaint, a damaged front enclosure was observed.The observed physical damage appeared to be the characteristics of mishandling.The front enclosure was replaced to address the issue.A review of the archive data showed (ua) 07 error messages; thus, confirming the reported complaint.The platform failed initial functional testing due to the (ua) 07 advisory message displayed upon powering up the platform; thus, confirming the reported complaint.The over-reporting single point load cell #1 was replaced to remedy the complaint.Following service, the platform passed the load cell characterization check.The autopulse platform passed the run-in test 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 were no similar complaints reported for autopulse with serial number (b)(6).

• 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: 18411564
• MDR Text Key: 331623126
• Report Number: 3010617000-2023-01082
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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: 02/05/2024

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2017
• 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