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 Patient Involvement (2645)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) displayed user advisory (ua) 02 (compression tracking error) message during the device test with the manikin was confirmed during the initial functional test and archive data review.The cause of the reported issue was due to the defective drivetrain motor, likely due to the normal wear and tear of the platform.The autopulse platform was manufactured in october 2008 and is almost 12 years old, well beyond the expected service life of 5 years.Visual inspection was performed and found no physical damage to the autopulse platform.Also, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance, unrelated to the reported complaint.The sticky clutch plate requires deburring to remedy the issue.The probable root cause for the encoder driveshaft problem was due to normal wear and tear.During the archive data review, multiple user advisory (ua) 02 occurred on the reported event date, thus confirming the reported complaint.The load cell characterization test confirmed both load cell modules are functioning within the specification.The autopulse platform passed the initial functional testing without any fault or error, however, during the run_in test using the 95% patient test fixture (lrtf), the platform failed with user advisory (ua) 17 (max motor on-time exceeded during active operation) error.The root cause of the user advisory (ua) 17 error was due to a defective drive train motor and is consequently related to the reported user advisory (ua) 02 error.To remedy the error, the defective drivetrain motor was replaced.After parts replacements, the platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with a good known test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with sn (b)(4).

Event Description

The customer reported that the autopulse platform (sn (b)(4)) displayed user advisory (ua) 02 (compression tracking error) error message several times during the device test with the manikin.The user verified correct position of the manikin and is secured with the shoulder strap on the platform.Per reporter, the user advisory (ua) 02 error also displayed during the test with several autopulse li-ion batteries.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
• 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: 10492871
• MDR Text Key: 205650238
• Report Number: 3010617000-2020-00862
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000697
• UDI-Public: 00849111000697
• 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: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• 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: 8700-0730-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2008
• 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