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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

During the device check, the autopulse platform (sn 23317) displayed a user advisory (ua) 12 (lifeband not present), and the customer noted a cracked cover on the platform.No patient involvement.

Manufacturer Narrative

The customer reported a complaint that the autopulse platform ((b)(6)) displayed a user advisory (ua) 12 (lifeband not present) error message was confirmed based on the review of the archive data but was not reproduced during the functional testing.The probable cause of the reported (ua) 12 message could be the lifeband not being fully inserted in the encoder spool shaft upon powering up the autopulse platform.The customer's secondary complaint of the cracked cover on the platform was confirmed during the visual inspection, as cracked top cover, and front and bottom enclosures were noted.The probable root cause for the observed physical damages could be due to user mishandling, such as a drop.During further visual inspection, various physical damages were observed, including a contaminated battery compartment, a damaged power button, and a worn-out udi label, unrelated to the reported complaint.The damaged parts need to be replaced to address the observed physical damages.In addition, unrelated to the reported complaint, observed body fluid ingress upon removing both the front and bottom enclosures.It was noted that the channel diecast is heavily contaminated by the fluid and will need to be replaced.Bio-cleaning needs to be performed to address the observed contamination.The root cause of the observed contamination and damages was likely attributed to user mishandling.Upon further inspection, unrelated to the reported complaint, it was noted that the ir port on the processor board had failed.The root cause was the failed processor board, likely due to internal contamination.The device's archive files were downloaded via the serial port.The processor board needs to be replaced to remedy the issue.The archive data was reviewed and contained a user advisory (ua) 12 error message around the reported event date, thus confirming the reported complaint.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 hangtag: advisory codes description and action, user advisory 12 indicates that autopulse has detected that the lifeband is not correctly installed.The recommended actions for this type of user advisory are: ensure that the band clip (underneath the device) is correctly seated in the drive shaft and can freely rotate after insertion.Functional testing of the autopulse platform failed due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error displayed upon power on, unrelated to the reported complaint.The root cause of the (ua) 07 error was the defective load cell module 2.The defective load cell needs to be replaced to address the (ua) 07 error.The customer reported (ua) 12 error was not reproduced during the functional testing.The lifeband clip detect switch inspection shows that the switch lever was able to close and is in a parallel position.The platform was verified using a standard belt test clip aid, the platform was tested and operated as intended without (ua) 12 error message.Waiting for customer approval for repair.

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18919232
• MDR Text Key: 337854997
• Report Number: 3010617000-2024-00214
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2012
• 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