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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281); Unexpected Shutdown (4019)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6).) either displays fault 43 (fan fault detected) message or shuts itself off was not confirmed during functional test or archive data review.The reported complaint was not reproduced during functional testing.Based on the archive, the platform was last powered on by the customer on (b)(6).2023.No other activity was recorded until the platform was returned to zoll for investigation in december.The complaint that the platform will not size the patient was confirmed based on functional testing.The platform displayed fault 16 (timeout moving to take-up position) during functional testing.When an error message is displayed, the lifeband will be unable to retract.During visual inspection, no physical damage was observed on the autopulse platform.The archive data review showed multiple fault 16 (timeout moving to take-up position) message from march 16 to april 11.The autopulse did not achieve the target depth for take-up within the specified time (~5 secs) due to the drive train motor having rust/corrosion at the brake assembly area.The brake body was seized from the rust/corrosion which prevents the brake from opening/closing during activation.This will cause fault 16 and prevent the platform from performing compressions.A review of the autopulse platform archive revealed that daily checks were not performed regularly.Performing regular daily checks and storing the device in a location with low humidity will reduce the likelihood of corrosive damage to the drivetrain motor and prevent the brake gap from seizing.The autopulse platform failed the initial functional test due to the displayed fault 16.Ipa (isopropyl alcohol) was used to clean and remove rust/corrosion at the brake housing area to remedy the issue.The brake gap was checked and verified to be within the specification of 0.008" ±0.001".The platform was tested with the large resuscitation test fixture (lrtf) without any fault or error.The customer reported complaint of fault 43 or that the platform shuts itself off could not be reproduced.Upon service completion, the console will be subjected to final functional testing to ensure that the device passes all testing criteria.Historical complaints were reviewed for service information related to the reported complaint of the platform will not size the patient, and there was no previous history of complaints for autopulse platform with sn(b)(6).

Event Description

During training by the staff, the autopulse platform (sn 36630) would not size the patient and either displays fault code 43 (fan fault detected) message or shuts itself off.No patient involvement.

• 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: 18432216
• MDR Text Key: 331883587
• Report Number: 3010617000-2024-00001
• 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

• 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: 12/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2021
• 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