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

Model Number MODEL 100

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184); Use of Device Problem (1670); Unexpected Shutdown (4019)

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

Event Date 08/24/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the autopulse platform for investigation.A follow-up report will be submitted when the investigation has been completed.

Event Description

During patient use on (b)(6) 2023, the customer reported the autopulse platform sn (b)(6) displayed user advisory (ua) 17 (max motor on-time exceeded during active operation) error message.The patient was average sized.They lifted up the lifeband and made sure everything was correct.They started the platform again and it did a few compressions, then the display screen on the autopulse started flickering and the autopulse turned off.The crew then did manual cpr for the rest of the call until the patient was transferred to hospital personnel.The crew stated after the call and back at the station, they turned the autopulse on again and the display screen was still flickering, and the platform would not work.It is unknown if any error message was displayed.

Event Description

Please see the following related mfr report: mfr #3010617000-2023-00792 for event 1.

Manufacturer Narrative

Additional information was added to b5 (describe event or problem).The reported complaint that the autopulse platform (sn (b)(6) displayed user advisory (ua) 17 (max motor on-time exceeded during active operation) error message was confirmed during the archive data review and functional testing.According to the archive, the motor was on for too long during active operation and the autopulse did not reach the target depth within the specification time.The root cause was related to a failure of the drivetrain motor.The complaint that the display screen was flickering and the platform turned off was not confirmed.The reported issue could not be reproduced during functional testing.Visual inspection of the returned platform was performed, and no physical damage was observed.A review of the archive data showed user advisory (ua) 17 (motor on for too long during active operation) error messages, confirming the reported complaint.Unrelated to the reported complaint, (ua) 07 (discrepancy between load 1 and load 2 too large) error message was also observed.During functional testing, the autopulse platform displayed (ua) 07 upon powering on, unrelated to the reported complaint.The load sensing system detected a weight/load imbalance between the two load cells.The load cell characterization results indicated the load cell module 2 was over-reporting.The failed load cell module was replaced to remedy the issue.The platform was then tested using the lrtf and the device stopped compression repeatedly to (ua) 17, thus confirming the reported complaint.The drivetrain motor was replaced to remedy the issue.Also unrelated to the reported complaint, fluid ingress corroded/damaged the blue case (top cover) metalized coating.The top cover was replaced to remedy the issue.Following service, the autopulse platform passed the run-in 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: 17782060
• MDR Text Key: 323848815
• Report Number: 3010617000-2023-00784
• 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,Followup
• Report Date: 10/20/2023

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
• Date Returned to Manufacturer: 09/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 10/05/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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