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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform sn (b)(6) stopped compressions several times was confirmed based on the archive data review and functional testing.A review of the archive data showed the autopulse platform had stopped compressions multiple times due to user advisory (ua) 17 (max motor on time exceeded during active operation) during active operation around the customer's reported complaint date.The ua17 advisory message was replicated during functional testing at zoll.The root cause of the reported complaint was the drivetrain motor brake gap being too wide (out of specification), most likely attributed to wear and tear.The autopulse platform was manufactured in january 2013 and is over 11 years old, well beyond its expected service life of 5 years.Visual inspection revealed that the front enclosure was broken, unrelated to the reported complaint, and likely attributed to wear and tear.The front enclosure was replaced to address this issue.The autopulse platform stopped compressions during the preliminary functional evaluation, confirming the customer's reported complaint.The platform failed the functional testing due to ua17 advisory messages.The too-wide (out of the specification) drivetrain motor brake gap was adjusted within the specification to address the ua17 advisory messages, which were verified to have occurred during active operation around the customer's reported complaint date.Following service, a load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.The autopulse platform was subjected to run-in tests using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number (b)(6).

Event Description

The customer reported that the autopulse platform (sn: (b)(6)) stopped compressions several times during patient use.The customer pulled up the lifeband and re-started the platform multiple times, but the issue was not resolved.The customer switched to manual cpr to continue the resuscitation attempt.The customer did not provide any further information.The patient's status information was requested, but the customer did not provide a response.

• 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 thoa nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18708346
• MDR Text Key: 335943372
• Report Number: 3010617000-2024-00128
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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