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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281); Noise, Audible (3273)

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

Event Date 01/22/2024

Event Type  malfunction  

Event Description

During shift check, the autopulse platform (sn: (b)(6) ) displayed fault code 16 (timeout moving to take-up position) upon powering up.The customer reported hearing a high pitched noise coming from the platform.To troubleshoot the issue, the customer tested the driveshaft to ensure the platform's drivetrain motor was not locked.The customer noticed that the driveshaft was stiff and would not rotate manually.No patient involvement.

Manufacturer Narrative

The reported complaint that the autopulse platform (sn: (b)(6) ) displayed fault code 16 (timeout moving to take-up position) upon powering up was confirmed in the archive data and during functional testing.The customer also reported hearing a high-pitched noise coming from the platform.This was also verified during the functional at zoll.The additionally reported complaint that the driveshaft was stiff and would not rotate manually was confirmed during functional testing.The root cause of fault code 16, the noise, and the stiff driveshaft was the seized brake gap of the malfunctioning drivetrain motor, likely attributed to the age of the device.The autopulse platform was manufactured in august 2008 and is over 15 years old, well beyond its expected service life of five years.Visual inspection showed that the front and bottom enclosures had cracks and several broken screw bosses, unrelated to the reported complaint.Although the observed physical damages appeared to be characteristics of harsh impacts, likely caused by user mishandling, wear and tear cannot be ruled out.The front and bottom enclosures were replaced to address the observed issues.The archive data revealed multiple fault code 16 on the reported event date, confirming the reported complaint.Further review of the archive data showed a fault code 24 (timeout moving to home position) on the reported event date.Fault code 24 occurred upon powering up the autopulse platform while pushing the start button.Fault code 24 occurred only once between multiple fault codes 16 and was not replicated during functional testing at zoll, but it was determined to be related to the stiff driveshaft due to the seized brake gap.The autopulse platform failed the initial functional test due to fault code 16 displayed during take up, confirming the reported complaint.While powering on the autopulse platform, there was no brake activation due to the seized brake assembly, leading to the drivetrain motor failing to rotate (initiate compression) and displaying fault 16.The brake housing area was cleaned and unseized using ipa (isopropyl alcohol), but fault code 16 persisted.Therefore, the malfunctioning drivetrain motor assembly was replaced to address all parts of the customer's reported complaint.Subsequently, the autopulse platform successfully passed a 20 minute run in test using the large resuscitation test fixture (lrtf) without any fault or error.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 fault or error.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaints were reported for the autopulse platform with serial number: (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: 18727681
• MDR Text Key: 335754465
• Report Number: 3010617000-2024-00139
• 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
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2008
• 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