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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4)) stopped functioning and turned off after performing a few compressions" was confirmed based on the analysis of archive data but not during the functional testing.No device malfunction was observed during the testing, and the platform functioned as intended.The archive showed fault code 28 (loss of clutch connectivity) and user advisory (ua) 20 (position out of range) error messages to have occurred on the reported complaint date.The possible root cause for the fault code 28 could be due to power distribution board failure or due to an internal component malfunction; however, no such malfunction was observed during the testing.The probable root cause for ua20 could be due to the encoder driveshaft not being within the normally acceptable range of positions, most likely attributed to normal wear and tear and/or possibly due to unintended user error.The reported complaint of "autopulse li-ion battery (sn: (b)(4)) was stuck in the battery compartment of the autopulse platform" was confirmed based on visual inspection.The autopulse platform was returned with the battery (sn: (b)(4)) stuck in the battery compartment.The root cause for the reported complaint was due to the damaged guide pins, likely attributed to user mishandling.During further visual inspection of the returned autopulse platform, it was noted that the front and bottom enclosures were severely broken, and the battery lock was observed bent.Also, the head restraint wires were damaged/cut.Furthermore, one load plate shoulder screw was missing.These observed physical damages were unrelated to the reported complaint and were appeared to be the characteristics of harsh impact due to user mishandling.The defective/damaged parts will be replaced to address the issues.Based on the archive data review, autopulse li-ion battery (sn: (b)(4)) was used on the reported event date.The autopulse was powered on and after performing 36 compressions, the platform stopped compressions; thus, confirming the reported complaint.According to the archive, the platform stopped compressions due to fault code 28 (loss of clutch connectivity) error message.The user re-started the autopulse to clear the error code.The autopulse was powered back on for a duration of 6 seconds, and then, the platform displayed ua20 (position out of range) error message.The user re-started the autopulse and cleared the error message.The platform was powered back on for a duration of 3 seconds and performed 4 compressions, and then, the platform stopped compressions and displayed the fault code 28.Then, the use of the autopulse platform was discontinued, possibly due to the customer inserting the battery (sn: (b)(4)) into the platform, which got stuck in the battery compartment of the autopulse platform.User advisory is a 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, fault code 28 error message alerts when the brake and clutch monitoring circuit detect a loss of connectivity on the brake driving circuit.This typically occurs if there is an internal component error or malfunction.If there is no internal component failure detected, this error message can be cleared when the user press restart.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.The returned autopulse platform passed the initial functional testing without any fault or error.During further functional testing, it was noted that encoder driveshaft was stiff and could not rotate smoothly, unrelated to the reported complaint.The root cause was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.The driveshaft clutch area needs to be deburred to remedy the identified stiff manual rotation of the driveshaft.Awaiting customer's approval for repair.

Event Description

During patient use, the autopulse platform (sn: (b)(4)) stopped functioning and turned off after performing a few compressions.In addition, the customer reported that autopulse li-ion battery (sn: (b)(4)) was stuck in the battery compartment of the autopulse platform.As per the customer, there were no breakages observed on either the battery finger latch or on the autopulse battery compartment.No consequences or impact to the patient.Please see the following related mfr report: mfr # 3010617000-2020-00623 for the autopulse li-ion battery (sn: (b)(4)).

• 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: 10172189
• MDR Text Key: 197406540
• Report Number: 3010617000-2020-00622
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 8700-0740-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2009
• 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