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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Date 03/17/2024

Event Type  malfunction  

Event Description

During the patient call, the autopulse platform (b)(6) stopped after performing several compression sessions.There were no user advisories visible.The platform was restarted and the lifeband was pulled up, but the issue was not resolved.The platform can be powered on but cannot perform compressions.The manual cpr was performed, followed by the lucas device.No consequences or impact to the patient.

Manufacturer Narrative

The reported complaint that the autopulse platform (b)(6) stopped after performing several compression sessions was confirmed based on the archive data review but not during the functional testing.Per the archive, the autopulse platform stopped compressions due to the user advisory (ua) 17 (max motor on-time exceeded during active operation) error message.No malfunction was found during testing at zoll, and the autopulse platform functioned appropriately and as intended.Visual inspection of the returned platform revealed a cracked front enclosure, unrelated to the reported complaint.This observed physical damage appeared to be characteristic of harsh impacts due to user mishandling.The damaged front enclosure needs to be replaced to address the issue.The archive data showed a (ua) 17 error message on the reported event date, thus confirming the reported complaint.User advisory is a clearable message designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse hangtag - advisory codes description and action, user advisory 17 is an indication that the lifeband is twisted or battery voltage is low.The recommended actions to take for this type of user advisory are: open lifeband, start manual cpr, check battery and lifeband, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.The autopulse platform passed the initial functional testing without any fault or error and the customer's complaint was not reproduced.The (ua) 17 error observed in the archive was not observed.The autopulse platform was subjected to the run-in test using the manikin and the 95% patient large resuscitation test fixture (lrtf) with a good known test battery for 15 minutes each without any fault or error.Awaiting the customer's approval for repair.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 19047540
• MDR Text Key: 339549869
• Report Number: 3010617000-2024-00302
• 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: 04/04/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2019
• 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