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 01/17/2024

Event Type  malfunction  

Event Description

As reported, the autopulse platform (sn (b)(6) displayed the user advisory (ua) 20 (position out of range) error message.It is unknown when the problem occurred.However, patient use information was requested but no additional information was provided.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6) displayed a user advisory (ua) 20 (position out of range) error message was not confirmed during archive review and the initial functional testing.There were no device deficiencies found during the evaluation of the returned platform that could have caused or contributed to the reported complaint.During visual inspection, there was no physical damage observed on the autopulse platform.The archive data review did not show any (ua) 20 error on or around the customer's reported event date.Unrelated to the reported complaint, the archive data indicated several (ua) 07 (discrepancy between load 1 and load 2 too large) and (ua) 17 (motor on for too long during active operation) errors around the reported event date.The (ua) 17 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 autopulse 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.Functional testing of the autopulse platform failed due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error displayed upon power on, unrelated to the reported complaint.The root cause of the (ua) 07 error was the defective load cell module 2.The defective load cell needs to be replaced to address the (ua) 07 error.Waiting on the customer's approval for service repair.

• 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: 18638422
• MDR Text Key: 334496843
• Report Number: 3010617000-2024-00137
• 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: 01/17/2024
• 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