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 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (b)(6) displayed fault code 08 (motor controller malfunction) was confirmed in the archive data but was not confirmed during functional testing.The returned autopulse platform functioned as intended, and the reported fault code 08 was not replicated.No physical damage was observed on the returned autopulse platform during visual inspection.The archive data review showed multiple fault codes 08 (motor controller fault detected) on the customer's reported event date, confirming the reported complaint.Fault code 08 was cleared and did not reproduce during functional testing at zoll.User advisory and fault code is normally a clearable error message, and it is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per zoll autopulse user advisory, fault, and alert id code reference: fault code 08 alerts the operator that the motor controller's built-in fault detection system signals a fault.This error occurs if the motor controller board or drive train motor is defective.This fault code may be cleared when the user presses restart/cycle power.The autopulse passed the preliminary functional test without any fault or error.Zoll is awaiting the customer's approval for repair.

Event Description

The customer reported that upon replacing the lifeband, the autopulse platform (b)(6) displayed fault code 08 (motor controller malfunction).Additionally, the customer requested zoll service to perform bio-cleaning of the platform.No further information was provided.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 thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19016517
• MDR Text Key: 339112627
• Report Number: 3010617000-2024-00283
• 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
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2011
• 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