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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Visual Prompts will not Clear (2281)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The customer reported that the autopulse platform (sn (b)(6)) wouldn't power on.Per the customer, the platform displayed a user advisory (ua) 12 (lifeband not present) message before the reported problem.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

The customer's complaint that the autopulse platform (sn (b)(6)) displayed a user advisory (ua) 12 (lifeband not present) message was confirmed during the functional testing and the archive data review.The root cause of the reported ua12 was that the switch lever was non-parallel to the switch case, which was likely attributed to the device's aging.The autopulse platform was manufactured in 2012 and is 11 years old, well past the expected serviceable life of five years.The customer's complaint that the autopulse platform wouldn't power on was not confirmed during the functional testing.The autopulse platform powered on with no issues.Unrelated to the reported complaint, a hole on the load plate cover that affects the watertight seal was noted upon visual inspection.The observed physical damage is likely attributed to wear and tear or user mishandling.The load plate cover will be replaced to address the observed physical damage.The archive data indicated several ua12 messages, confirming the reported complaint.The autopulse platform failed initial functional testing due to ua12 displayed upon powering on, confirming the reported complaint.The lifeband detect switch was adjusted within the specification to address the reported ua12.The autopulse platform was further tested and passed the test without error or fault.The brake gap inspection was performed, and the brake gap was verified to be within the specification.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with sn (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: 18271826
• MDR Text Key: 329808299
• Report Number: 3010617000-2023-01013
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: 11/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2012
• 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