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

Model Number MODEL 100

Device Problems No Display/Image (1183); Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the customer was unable to read the displayed user advisory because the lcd screen was unreadable" was confirmed during the functional testing.The root cause of the reported complaint was a defective backlight of the lcd display, likely as a result of normal wear and tear.The autopulse platform is a reusable device and was manufactured in 2010, and it is 10 years old, well beyond its expected service life of 5 years.The reported complaint of "the user was unable to clear the unknown displayed user advisory" was confirmed based on the archive data review.Per archive, the last time the autopulse platform was used to compress an object similar to a human was on 09 july 2020, and there was a user advisory (ua) 20 (position out of range) error message observed to have occurred on that date.Based on the archive, the user was unable to clear the error message, and the use of the autopulse platform was discontinued; thus, confirming the reported complaint.The ua20 was not replicated during the functional testing, and no device malfunction was found that could have caused or contributed to the occurrence of the ua20 error message.The probable root cause of the ua20 error was the driveshaft not to be at "home" position, most likely attributed to unintended user error.User advisory is the clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per auto pulse user advisory list, user advisory 20 alerts when the drive shaft is not within the specified range of positions.This typically occurs if the autopulse attempted to perform compressions with a cut lifeband installed which allowed the driveshaft to rotate out of operating range.Also, this error message can be triggered due to an internal component error or malfunction.This error message can be cleared by returning the drive shaft to home position using the administrative menu.Visual inspection of the returned platform was performed, and no physical damage was observed.The autopulse platform passed the initial functional testing without any fault or error.During the functional testing, it was noted that the backlight of the lcd was not lighting up; however, the display was still readable in daylight circumstances.The defective lcd display was replaced to remedy the fault.Following service, the autopulse was subjected to 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.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

During patient use, the customer was unable to read the user advisory (ua) that was displayed by the autopulse platform (sn: (b)(4)) because the lcd screen was unreadable.The user was unable to clear the unknown displayed user advisory, and therefore, the use of the autopulse platform was discontinued, and manual cpr was performed.No further information was provided by the customer.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.As reported, the autopulse platform backlight was noted to be defective a few months prior to the reported event; however, the customer had declined to send the device for service/repair because the lcd screen was still readable at the time.Per the archive data review, the unknown error message observed by the customer was user advisory (ua) 20 (position out of range) occurred on july 09, 2020.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10324367
• MDR Text Key: 200433605
• Report Number: 3010617000-2020-00753
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2020
• 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: 07/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2010
• 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