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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

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

Event Date 12/12/2023

Event Type  malfunction  

Event Description

During a call involving a 67-year-old approximately 220lb male patient with a history of recent hernia repair, the autopulse platform (sn (b)(6) shut off.No error message was observed.When attempting to restart the platform, it displayed a "low battery" message.The battery level of the autopulse li-ion battery #1 (sn unknown) went from fully charged to 2 bars.The battery lasted approximately 15 minutes.A new autopulse li-ion battery #2 (sn unknown) was inserted, and the status leds showed 4 bars.However, the platform shut off shortly after.This occurred a third time with a third battery (sn unknown).The second and third batteries each lasted less than 5 minutes before the platform shut off.Manual compressions were performed for about 15-20 minutes.No impact or consequence to the patient was reported other than that manual compressions were required.The three batteries are performing as intended in other autopulse platforms.

Manufacturer Narrative

The reported complaint that the autopulse platform (b)(6) shut off during compressions was confirmed during the archive data review but not during functional testing.The platform performed as intended during testing.Although the complaint could not be duplicated, the power distribution board was replaced as a precaution against any possible voltage spikes.Upon visual inspection, unrelated to the reported complaint, the front enclosure was observed to be cracked.The observed physical damage appeared to be the characteristic of user mishandling.The front enclosure was replaced to address the issues.The archive data review showed three voltage spikes followed by a drop in voltage and a (ua) 17 (motor on for too long during active operation) error, related the reported complaint.Two of the batteries the customer was using during this deployment (b)(6) are over 4 years old and past their service life.The use of these batteries should be discontinued.The autopulse platform passed the initial functional testing without any fault or error.The autopulse platform was tested with 4 different size manikins and 3 different autopulse li-ion batteries.The device never shut off or powered down.The customer reported complaint and (ua) 17 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 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.Following service, the autopulse platform passed the run-in test and load cell characterization test 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: 18445824
• MDR Text Key: 331986356
• Report Number: 3010617000-2024-00011
• 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: 01/04/2024

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2022
• 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
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 100 KG