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

Model Number MODEL 100

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that "the autopulse platform (s/n (b)(4) displayed user advisory (ua) 12 (lifeband not present)" was confirmed based on the archive data review but was not confirmed during functional testing.The possible root cause of the reported ua12 was the band clip on the lifeband not properly engaging the safety switches in the driveshaft because either there was no lifeband installed or the lifeband was improperly installed, likely attributed to user error.User advisories are clearable error messages; per the battery hangtag - advisory codes description and action, user advisory 12 indicates that the autopulse has detected that the lifeband is not properly installed.The recommended actions for this type of user advisory are: ensure that the band clip (underneath the device) is correctly seated in the driveshaft and can freely rotate after insertion.During visual inspection, based on the photos provided by the zoll service team, a large crack on the top cover, and cracks on the screw wells on the front and bottom enclosures, unrelated to the reported complaint.The observed physical damages appeared to be the characteristic of harsh impacts due to user mishandling.The damaged parts needs to be replaced to address the observed issues.The archive data review showed multiple ua12 errors, thus confirming the reported complaint.Also observed in the archive and unrelated to the reported complaint, multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) errors.During the investigation, a load cell characterization test was performed and confirmed both load cell modules were functioning within the specification.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.In this reported complaint, the ua07 occurred likely due to either the patient/manikin or the autopulse platform being out of position, placed on an uneven surface, moved during compressions, or the patient/manikin was not properly centered/aligned on the platform.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.The autopulse platform passed the initial functional testing without any fault or error.Awaiting customer's approval for service repair.

Event Description

During shift check, customer reported that the autopulse platform (serial #(b)(4) displayed user advisory "(ua) 12" (lifeband not present) upon power on.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: 14881661
• MDR Text Key: 295262466
• Report Number: 3010617000-2022-00742
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• 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: 06/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2019
• 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