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 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the platform for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.

Event Description

As reported, the autopulse platform (b)(6) displayed fault code 16 timeout moving to take-up position) 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 fault code 16 (timeout moving to take-up position) error message was confirmed during functional testing and archive data review.The root cause for the reported complaint was due to a failed motor controller board, likely due to a defective component.A visual inspection was performed and found no physical damage to the returned autopulse platform.A review of the platform archive data was performed and it showed fault code 16 occurred around the reported event date, thus confirming the reported complaint.The initial functional testing of the platform could not be performed due to fault code 16 displayed upon powering on.Thus, confirming the reported complaint.To remedy the fault, the motor controller board was replaced.Following service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any fault or error.The autopulse platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial (b)(6).

• 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: 18044569
• MDR Text Key: 327485249
• Report Number: 3010617000-2023-00934
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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,Followup
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2023
• 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