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

Model Number MODEL 100

Device Problems Retraction Problem (1536); Visual Prompts will not Clear (2281)

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

Event Date 09/12/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported a complaint that "the lifeband did not retract, and the autopulse platform displayed user advisory (ua) 18 (max take-up revolutions exceeded) message" was confirmed based on the archive data review but was not confirmed during the functional testing.No device malfunction was observed during the testing, and the autopulse platform functioned as intended.Based on the archive, there was no weight on the autopulse platform when it displayed ua18.When there is no weight on the device, the autopulse is designed to pull the lifeband all the way down and prompts ua18.A crack on the front enclosure was observed upon visual inspection, unrelated to the reported complaint.Based on the photo provided by the service personnel, a hairline crack was noted across the screw well area of the front enclosure, likely attributed to wear and tear or user mishandling.The front enclosure needs to be replaced to address the observed physical damage.The autopulse platform was manufactured in 2012 and is 11 years old, well past the expected serviceable life of 5 years.The archive data indicated several ua18 messages on the reported event date, thus confirming the reported complaint.In addition, unrelated to the reported complaint, further review of the archive data indicated multiple ua02 (compression tracking error) and ua07 (discrepancy between load 1 and load 2 too large) messages around the reported event date.There was very little or no weight on the device at the time of these errors.User advisory is a clearable message designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the battery hangtag - advisory codes description and action, user advisory 18 indicates that the autopulse® has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.In this case, revert to manual cpr.Per the battery hangtag - advisory codes description and action, user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.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, press restart to clear the ua.The autopulse platform passed the functional testing with no fault or error.The customer reported ua18, and the additional uas observed in the archive were not reproduced during the functional testing.A load cell characterization test confirmed that both cell modules function within the specification.Zoll is awaiting customer approval for service repair.

Event Description

During shift check, the lifeband did not retract, and the autopulse platform (sn (b)(4)displayed user advisory (ua) 18 (max take-up revolutions exceeded) message.No patient involvement.

• 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: 15569072
• MDR Text Key: 303645026
• Report Number: 3010617000-2022-01797
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 10/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2012
• 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