MAUDE Adverse Event Report: ZOLL CIRCULATION 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 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

The customer reported a complaint that the autopulse platform (sn (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message was confirmed during the functional testing and archive data review.The root cause of the (ua) 07 error was due to the failed load cell module.As reported, the autopulse platform was dropped by the customer.Therefore, the failed load cell was attributed to user mishandling.During visual inspection, there was no physical damage observed on the autopulse platform.The archive data indicated several (ua) 07 errors around the reported event date, thus, confirming the customer's reported complaint.Also, the archive data showed the (ua) 17 (motor on for too long during active operation) errors, unrelated to the reported complaint.The error was cleared by the customer and was not duplicated during the platform testing.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 17 is an indication that the lifeband is twisted, or battery voltage is low.The recommended actions to take for this type of user advisory are: open lifeband, start manual cpr, check battery and lifeband, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.The autopulse platform failed the initial functional testing due to the (ua) 07 error message displayed upon powering on, thus confirming the customer complaint.The load sensing system of the device has detected a weight/load imbalance between the two load cells.The load cell characterization test results confirmed that load cell module 2 was exceeding normal parameters.The load cell module needs to be replaced to address the reported complaint.Waiting on the customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for the autopulse platform with sn (b)(6).Ccr (b)(6) , reported on (b)(6) 2018.The load cell was replaced to address the (ua) 07 error.

Event Description

Per the reporter, the autopulse platform (sn (b)(6) was dropped.During the platform power-on, the device displayed the 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.

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18638421
• MDR Text Key: 334497146
• Report Number: 3010617000-2024-00095
• 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: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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