MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; 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 Type  malfunction  

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform (b)(4) displayed user advisory (ua) 41 (patient temperature sensor failure) error message upon powering on" was confirmed during the functional testing and based on the review of the archive data.The root cause for the ua41 error was a defective temperature sensor, likely attributed to the device's aging.The autopulse platform was manufactured in 2015 and is six years old, past the expected serviceable life of 5 years.During visual inspection, no physical damage was observed.The archive data indicated several ua41 errors; thus, confirming the customer reported complaint.The autopulse platform failed initial functional testing due to the ua41 error message; thus, confirming the customer-reported complaint.The temperature sensor was replaced to address the reported ua41 error.A load cell characterization test was performed and confirmed that both cell modules function within the specification.Following the temperature sensor replacement and service completion, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse platform with sn (b)(4).

Event Description

During shift check, the autopulse platform (b)(4) displayed user advisory (ua) 41 (patient surface temperature sensor failure) error message upon powering on.The autopulse platform was placed on the hard surface when it displayed the user advisory.The customer stated that the autopulse platform was usually stored in the ambulance.No patient involvement.

• 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13119609
• MDR Text Key: 282986175
• Report Number: 3010617000-2021-01215
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/30/2021

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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2015
• 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