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

Model Number MODEL 100

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

The report of the platform does not retract the lifeband was confirmed through the evaluation of the autopulse platform (sn (b)(4)).Functional testing of the platform revealed a user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message on the user control panel during initial power up and during archive data review.To remedy the issue, the driveshaft was rotated back to the home position.The likely root cause of the issue was due to user error.Per the autopulse user guide instruction, to clear user advisory (ua) 45, 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 user advisory will persist until the driveshaft is returned to its home position.The autopulse platform passed functional test after drive shaft was rotated to the home position.As part of routine service during testing, the platform was examined and found damaged front enclosure, unrelated to the reported issue.The autopulse platform is a reusable device and was manufactured in may 2013 and is 6 years old, beyond the expected service life of five years.Therefore, this type of physical damage is characteristic of normal wear and tear for the life of the device.The archive data review indicated multiple error message user advisory (ua) 45 around the reported event date, thus confirming the customer complaint.In addition, unrelated to the reported issue, archive data noted user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message around the reported complaint date.User advisory is a clearable error message and is designed into the platform to alert the operator that the autopulse platform has detected one of several conditions.User advisory (ua) 07 is an indication that the load sensing system has detected a weight/load imbalance between the two load cells.The recommended actions to take for this type of user advisory are: ensure the patient is properly aligned (armpits on the yellow line), deploy the shoulder restraint to mitigate patient movement and press restart to clear the user advisory.The platform was further tested with large resuscitation testing fixture, (lrtf) equivalent to (b)(6) pound patient with good known test batteries for 15 minutes and passed all functional testing criteria and met all required specifications.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 the shift check, after the new lifeband was placed on the autopulse platform (sn (b)(4)), the platform displayed the "lift band" message.The user lifted the lifeband, however, the platform would not retract.There was no user advisory displayed on the platform.No additional information was provided.No patient involvement.

• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 9329727
• MDR Text Key: 167242167
• Report Number: 3010617000-2019-01052
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2019
• Initial Date FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2008
• 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