MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Unexpected Shutdown (4019)

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

Event Date 12/17/2021

Event Type  malfunction  

Event Description

During a functional demonstration of the autopulse platform (s/n (b)(4)), the platform powered on with no issues or errors, but it failed to retract the lifeband to start compressions.Following this, the autopulse platform powered off unexpectedly.As per the customer, the battery was fully charged (showing 4 solid green led lights) before inserting it into the platform.The customer stated that the driveshaft of the platform did not rotate as intended for the device to function.The customer has only one autopulse platform, and therefore, the lifeband was not tested with another platform.However, the customer tested the autopulse platform with another lifeband, and the same issue occurred.No patient involvement.

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The reported complaint that "the autopulse platform (s/n (b)(6) failed to retract the lifeband" was confirmed in the archive data and during functional testing.The archive data showed fault code 16 (timeout moving to take-up position) on and around the customer's reported event date.The fault code 16 was replicated during functional testing upon powering up the platform.Per design, the autopulse platform will self-power off 2 minutes after an error code is encountered, and if there is no user activity.Therefore, the customer's reported complaint that "the autopulse platform powered off unexpectedly after it failed to retract the lifeband" was an intended function of the device.The additionally reported complaint that "the driveshaft of the platform did not rotate as intended" was confirmed during functional testing.The root cause of the reported complaints was a seized brake gap, possibly resulting from neglect/user handling.A review of the archive data revealed that frequent daily checks were not performed by the customer, and the storage condition of the platform is not known.Frequent daily device checks and storing the autopulse platform in a low humidity location could help prevent the brake gap from seizing.Also, no documented report was found showing that regular preventative maintenance (pm) was performed on this platform since it was acquired by the customer in 2020.The lack of regular maintenance could lead to degradation of the mechanical components of the drivetrain, including brake seizure.Visual inspection of the returned autopulse platform was performed, and no physical damage was observed.Functional testing failed as the autopulse platform was unable to retract the lifeband, confirming the reported complaint.Then, the platform displayed fault code 16 during take-up as there was no brake activation.Inspection found the brake assembly to be seized, preventing the lifeband from being retracted, causing fault code 16, and resulting in stiffness of the driveshaft.If the brake gap is seized, the brake does not release, and that also causes the driveshaft to become hard or impossible to rotate.The brake gap was cleaned using ipa (isopropyl alcohol) to release it, and it was then adjusted to remedy the faults.After cleaning and adjusting the brake gap, the autopulse platform successfully passed a run-in test using the 95% large resuscitation test fixture (lrtf) with known-good test batteries for 15 minutes.Following service, the autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged 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 reported for autopulse platform with serial number (b)(6).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13216712
• MDR Text Key: 284144410
• Report Number: 3010617000-2022-00031
• 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: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• 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