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

Model Number MODEL 100

Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670)

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

Event Date 11/11/2023

Event Type  malfunction  

Event Description

The customer reported the autopulse platform (sn 35404) would not compress the chest during an event involving a 48-year-old male patient.No user advisories were observed because the display was unreadable.The platform turns on but does not perform as intended.The crew switched to another platform.No impact or consequence to the patient.

Manufacturer Narrative

The reported complaint that the display of the autopulse platform (sn (b)(6).) was unreadable was confirmed during visual inspection and functional testing.The likely root cause was software issue.After reloading the 6.02.01 software, the screen was clear and readable.The processor pca was replaced as a precaution against further software corruption.The reported complaint that the platform will not start compressions was confirmed during the archive data review and functional testing.The root cause was the unreadable screen.On the event date, the archive showed multiple error messages.Since the screen was unreadable, the user was unable to determine or clear the displayed error message to start compressions.Upon further visual inspection, unrelated to the reported complaint, the front and bottom enclosure, top cover, and battery lock were damaged.The observed physical damage appeared to be the characteristic of user mishandling.The front and bottom enclosure, top cover, and battery lock were replaced to address the issues.A review of the archive data showed user advisory (ua) 02 (compression tracking error), (ua) 07 (discrepancy between load 1 and load 2 too large), and (ua) 12 (lifeband not present) on the reported event date, related to the reported complaint.The autopulse platform failed initial functional testing due to the screen being unreadable.The 6.02.01 software was reloaded and the processor pca was also replaced to remedy the complaint.Subsequently, the platform passed a 15-minute functional test with the large resuscitation testing fixture (lrtf), equivalent to a 250-pound patient.The platform passed the load cell characterization check.The (ua) 02, (ua) 07, and (ua) 12 messages observed in the archive could not be reproduced.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 battery hangtag - advisory codes description and action, user advisory 2 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 maintenance guide and autopulse user advisory list, user advisory 07 occurs when the load sensing system has detected a weight/load imbalance between the two load cells.The device does not need to be performing compressions for this to occur; it may happen at any time when the device is powered on.User advisory 07 is an indication that the patient/manikin is out of position or the patient/manikin is not properly centered.The recommended actions to take for this type of user advisory are: ensure the patient/manikin is properly aligned (armpits on the yellow line), deploy the shoulder restraint to reduce patient/manikin movement, press restart to clear the ua.Per the battery hangtag - advisory codes description and action, user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft can freely rotate after insertion.Following service, the autopulse platform passed the run-in test until discharged without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints for autopulse platform with sn (b)(6).

• 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 thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18432217
• MDR Text Key: 331882257
• Report Number: 3010617000-2024-00002
• 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
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2020
• 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
• Patient Age: 48 YR
• Patient Sex: Male