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 Consequences Or Impact To Patient (2199)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of user advisory - user advisory - "ua02" (compression tracking error) error message on the autopulse platform (serial # (b)(4)) was confirmed during functional testing and during archive data review.The root cause of the reported ua02 error message was due to damaged load cells in which were likely attributed to mishandling such as a drop.The reported complaint of user advisory - "(ua)12" (lifeband not present) error message on the returned autopulse platform was not confirmed during functional testing but confirmed during archive data review.Per the autopulse resuscitation system model 100 user guide, ua12 error message recorded in the archive data is easily a clearable by the user.The ua12 error message alerts the lifeband is not properly installed.This can be cleared by ensuring that the lifeband is properly installed and restarting the platform.The reported complaint of user advisory - "ua17" (max motor on time exceeded during active operation) error message on the returned autopulse platform was not confirmed during functional testing but confirmed during archive data review.Per the autopulse resuscitation system model 100 user guide, ua17 error message recorded in the archive data is easily a clearable by the user.The ua17 error message alerts the user that the drive motor did not reach the target depth within specification in which is likely attributed to the stiffness of the patient's chest, a twisted lifeband, and/or the length of time the platform was used performing continuous compression.During visual inspection, a frayed patient's head restraint wire, several screws holders are torn and/or broken on the encoder and motor covers were observed on the returned autopulse platform, unrelated to the reported complaint.These types of physical damages are characteristics of mishandling and/or wear and tear.The returned autopulse platform was manufactured in may 2007 and is 13 years old, well past beyond its expected serviceable life of 5 years.The top cover was replaced to address the frayed patient's head restraint wire and the torn/broken screws were replaced.During archive data review, multiple ua02, ua12 and ua17 errors were recorded.Thus, confirming the reported complaint.Initial functional testing failed due to "ua 02" (compression tracking error) error message when the returned autopulse platform was powered on and also, the load cell characterization failed, ua07 (discrepancy between load 1 and load 2 too large).The investigation findings revealed that the root cause of ua02 and ua07 was due to damaged load cells.The load cells were replaced to address these error messages.After service repair completion, the returned autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The load cell characterization passed.The autopulse platform passed all other functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

Customer reported that the autopulse platform (serial # (b)(4)) displayed user advisory - "(ua)12" (lifeband not present), "ua17" (max motor on time exceeded during active operation) and "ua 02" (compression tracking error).Patient use information was requested but no additional information was provided, therefore patient use is unknown.

• 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: 10059548
• MDR Text Key: 191859271
• Report Number: 3010617000-2020-00478
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• 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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2007
• 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