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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Unexpected Shutdown (4019)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

Patient 3 of 3.During a call, after providing two compressions, the autopulse platform (sn (b)(6)) powered off after displaying a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The crew was unable to clear the advisory and immediately performed manual cpr for 45 minutes.Rosc was achieved.No consequences or impact to patient.Per the reporter, the platform was tested with a manikin after the call and functioned as intended.For patient 1 of 3, see ccr 79165, mfr 3010617000-2023-01102.For patient 2 of 3, see ccr 79166, mfr 3010617000-2023-01103.

Manufacturer Narrative

The customer reported complaint that the autopulse platform (sn (b)(6)) powered off after displaying user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message was confirmed based on the archive data review but was not confirmed during the functional testing.Based on the archive, the autopulse platform had a "time out" incident after (ua) 07 on the reported event date, indicating that the autopulse automatically powered off after the platform displayed the ua/fault error messages.No device malfunction was observed that could have caused or contributed to the reported (ua) 07 error.The (ua) 07 error was not replicated throughout the testing at zoll.During visual inspection, no physical damage was noted.The archive data indicated several (ua) 07 errors on the reported event date, thus confirming the customer's reported complaint of (ua) 07.In addition, unrelated to the reported complaint, fault 28 (loss of clutch connectivity), fault 29 (loss of brake connectivity), and ua 17 (max motor on time exceeded during active operation) error messages were observed, however, they were not duplicated during the functional testing at zoll.User advisory is a clearable message designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse maintenance guide and autopulse user advisory list, user advisory 07 occurs when the load sensing system has detected a weight/load imbalance between the two load cells.The device does not need to be performing compressions for this to occur; it may happen at any time when the device is powered on.User advisory 07 is an indication that the patient/manikin is out of position, or the patient/manikin is not properly centered.The recommended actions to take for this type of user advisory are: ensure the patient/manikin is properly aligned (armpits on the yellow line), deploy the shoulder restraint to reduce patient/manikin movement, and press restart to clear the ua.Per the autopulse 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.The autopulse platform passed the initial functional testing without errors or faults.A load cell characterization test confirmed that both cell modules function within the specification.The probable root cause for the fault 28 and fault 29 errors observed in the archive was due to the failed power distribution board (pdb) as it may have had intermittent technical problems that were not able to be directly identified during testing.As a precautionary measure, the pdb needs to be replaced to address the faults.Furthermore, there was wear on the shaft bearing of the encoder, indicating that the encoder needs to be replaced, unrelated to the reported complaint.During a further device inspection, unrelated to the reported complaint, the drivetrain motor brake assembly air gap was measured too narrow, being out of specification.The probable root cause of this issue is attributed to wear and tear.The autopulse platform was manufactured in september 2017 and is over 6 years old, beyond its expected service life of 5 years.The brake gap was adjusted within the specification to address the issue.Awaiting the customer's approval for repair.

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18407208
• MDR Text Key: 331691031
• Report Number: 3010617000-2023-01072
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/27/2023

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2017
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 82 KG