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

Model Number MODEL 100

Device Problem Complete Loss of Power (4015)

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

Event Date 04/28/2023

Event Type  malfunction  

Event Description

During patient use, the customer reported that the autopulse platform (sn (b)(6)) stopped compression and shutdown.Per reporter, the battery was not replaced because the customer was pulling up to the hospital.The battery used was fully charged, and they changes out the battery every morning at shift change with a full one from the charger.No consequences or impact to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform (sn (b()(6)) stopped compression and shutdown" was not confirmed during functional test.No device malfunction was observed, and the autopulse platform functioned as intended.However; the archive data review showed user advisory (ua)01 (low battery warning) and ua04 (battery charge state too low) errors occurred on the reported event date, which indication that the autopulse platform (sn (b)(6)) did stopped compression and shutdown, confirming the reported complaint.Based on the li-ion battery (s/n: (b)(6)) evaluation, the battery was left in the autopulse platform for 47 days without charging.This could potentially result in a lower charge capacity.Upon visual inspection revealed a cracked front enclosure, unrelated to the reported complaint.The observed physical damage was likely attributed to user mishandling, such as a drop.The front enclosure was replaced to remedy the observed physical damage.During archive data review, several user advisory ua01 (low battery warning) and ua04 (battery charge state too low) errors on the reported event date, thus confirming the reported complaint.Also, ua02 (compression tracking error) and ua12 (lifeband not present) errors, unrelated to the reported complaint.These uas were not replicated during functional test.User advisory is normally a clearable error message and is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse user advisory list, user advisory 01 indicates that the battery needs to be charged because less than 5 minutes of battery voltage is left.The recommended action for this type of user advisory is to replace the battery and press restart to clear the ua.Per the autopulse® hangtag - advisory codes description and action, user advisory 04 is an indication that the battery is uncharged or faulty.The recommended actions to take for this type of user advisory are: open lifeband, start manual cpr, replace the battery, perform start-up, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.Per the autopulse® hangtag - advisory codes description and action, user advisory 02 is an indication that the autopulse has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.Per the autopulse® hangtag - advisory codes description and action, user advisory 12 error message alerts when the lifeband is not properly installed.This can be cleared by ensuring that the lifeband is properly installed and restarting the platform.During the functional testing, autopulse platform passed the final run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without fault or error.Following service, the autopulse platform passed the run-in and final tests without fault or error.

• 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
• MDR Report Key: 17098968
• MDR Text Key: 316884039
• Report Number: 3010617000-2023-00505
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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,Followup
• Report Date: 07/27/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 07/24/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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