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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

The patient was placed on the autopulse platform (sn (b)(4) during the call.The platform was powered on and the lifeband bands were pulled up to start the compressions, however, after the start button was pressed, the platform displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The issue persisted after swapping out the lifeband and the battery.Immediately, the crew reverted to manual cpr.No consequences or impact to the patient.Back at the station, the autopulse platform was tested with a mannequin after the lifeband and the battery were replaced and the platform displayed a (ua) 07 error message again.Per the reporter, the platform has not been dropped.

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform (sn (b)(4) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message" was confirmed during the functional testing and archive data review.The root cause of the (ua) 07 was due to failed load cell, likely attributed to a failed component, or mishandling such as a drop.A visual inspection was performed, and no physical damage was observed.The archive data indicated several (ua) 07 errors around the reported event date, thus, confirming the customer's reported complaint.The autopulse platform failed initial functional testing due to (ua) 07 displayed upon powering on, thus, confirming the customer's reported complaint.The load sensing system of the device has detected a weight/load imbalance between the two load cells.The load cell characterization result indicated a failed load cell module 2.The load cell needs to be replaced to address the reported complaint.Waiting for customer approval for repair.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 sn (b)(4).

• 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: 16066384
• MDR Text Key: 306326750
• Report Number: 3010617000-2022-02124
• Device Sequence Number: 1
• Product Code: DRM
• 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: 12/29/2022

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2021
• 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