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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (sn 21234) involved in the reported complaint will not be returned for evaluation because the customer cleared the user advisory (ua) 18 (max take-up revolution exceeded) error message by following the instructions provided by zoll technical support.The root cause of the (ua) 18 error was that no patient or mannequin was placed on the platform when the lifeband was retracted, likely attributed to unintended user error.The customer tested the autopulse platform, and the platform functioned as intended.Therefore, service was not required to be performed by zoll.The user advisory is normally a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 18 occurs when the driveshaft has traveled past the maximum number of revolutions without detecting a patient/manikin (weight).As take-up is performed, the driveshaft moves the lifeband past the maximum allowable take-up depth without detecting a patient/manikin (weight), which results in a load change at the load plate.The take-up position is achieved when the load plates sense an additional 6 lbs.Of load compared to the pre-take-up load.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient/manikin and the band are properly aligned, and press restart.

Event Description

During shift check, the autopulse platform (sn 21234) displayed user advisory (ua) 18 (max take-up revolution exceeded) after the new lifeband was placed.The issue persisted after several lifebands were replaced.Zoll technical support representative advised the customer that (ua) 18 is observed when there is no patient/manikin (weight) on the platform.The customer placed the manikin on the platform and the (ua) 18 error was cleared.The platform was placed back for clinical use.No patient involvement.

• 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): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18919230
• MDR Text Key: 337854401
• Report Number: 3010617000-2024-00212
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2007
• 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