MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) stopped compressions during patient use was not reproduced during functional testing of the platform.There was no device deficiency found during evaluation of the platform to indicate a functional issue.The device was functionally tested using a good known autopulse li-ion battery with a large resuscitation test fixture for 10 minutes and operated with compression without error.The investigation performed a load characterization check and verified that the load cells are within specification.Review of the archive data confirmed the occurrence of multiple user advisory (ua) error messages on (b)(6) 2018.The events recorded on (b)(6) 2018 indicated that the platform was used and displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large), (ua) 02 (compression tracking error), (ua) 18 (maximum take-up depth exceeded), (ua) 45 (not at "home" position after power-on/restart), (ua) 21 (drive shaft turns in wrong direction), (ua) 12 (lifeband not detected) and (ua) 20 (drive shaft out of range).The user was unable to clear the error messages.These user advisories are attributed to the user error.This confirms the reported complaint.Note that user advisory error messages are designed into the platform when one of several conditions are detected.The ua 07 alerts the user that the load sensing system has detected a weight/load imbalance between the two loads cells might be due to the patient not oriented on the autopulse platform correctly or the patient has shifted during compression.The ua 2 error is raised when the drive shaft rotates and tightens the lifeband (to compress the chest), the load cells do not see the expected increase in load, typically when there is no patient on the autopulse platform or the patient is not placed correctly.The user advisory 2 is also raised if the lifeband is opened during active operation.The ua 12 error message is an indication that the autopulse has detected that the lifeband is not properly installed.The most likely cause of the platform exhibiting ua12 was determined to have been a movement of the patient and platform, causing the lifeband to become detached from the platform.The ua 18 error message alerts the operator that either the patient was too small or there was no load change detected during take-up of the lifeband.The ua 20 error message was due to the encoder drive shaft not being within the normally acceptable range of positions.Typically, if the ua 45 is not resolved properly, it leads to ua 20 because the drive staff is not restored at the home position.The ua 21 error message indicates the computed compression target position exceeds allowable revolutions.The ua 45 indicates that the drive shaft is not at the home position when the autopulse is powered on.Per the autopulse user guide instruction, to clear the error message, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.The patient should be properly positioned on top of the platform.Restarting the platform will clear the ua error messages.No physical damage was observed during the visual inspection.The encoder drive shaft does not rotate smoothly, exhibits binding and resistance, unrelated to the reported issue.Clutch plate deburring was performed to remedy the issue.Historical complaints were reviewed for service information related to the reported complaint and no previous history of complaint was reported for the autopulse platform with serial number (b)(4).

Event Description

During patient use, the customer reported that the autopulse platform (sn (b)(4)) stopped compressions after several minutes of operation and displayed an unknown error message followed by initialization error.No additional information was provided.There is no report of patient impact or consequences.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: 7727711
• MDR Text Key: 115358660
• Report Number: 3010617000-2018-00721
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• 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: 07/02/2018
• Date Manufacturer Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2017
• 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