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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2024

Event Type  malfunction  

Event Description

The customer reported a malfunction during treatment of 62-year-old male suffering from cardiac arrest where the autopulse platform (b)(6) failed to provide compressions and displayed "patient not aligned, pull band" error messages.The band was pulled up multiple times and the autopulse li-battery was replaced, however the issue persisted.The crew reverted to manual cpr.Upon return to the base, the platform was tested with a dummy and worked normally for 20 mins.Patient's status information was requested but the customer did not provide a response.

Manufacturer Narrative

The autopulse platform involved in the reported complaint will not be returned to a zoll service depot for evaluation.Upon return to the base after the patient event, the customer tested the platform with a dummy and it worked normally for 20 mins.The platform is currently performing as intended.Since the issue was not reproduced, service was not required to be performed by zoll.

• 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): ZOLLCIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19154311
• MDR Text Key: 341434582
• Report Number: 3010617000-2024-00332
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/22/2024

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: 8700-0700-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 62 YR
• Patient Sex: Male