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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 12/16/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event for the autopulse platform (sn# (b)(4)) is confirmed through functional testing and archive data review.Upon visual inspection, observed damage on the front enclosure of the autopulse platform, unrelated to the reported complaint.The front enclosure has been replaced to remedy the issue.Upon powering on, the platform displayed ua45 (drive shaft not at home position) error code during initial functional testing.The drive shaft has been rotated to home position to clear the ua45 error message.The archive data review showed multiple occurrence of ua07 (discrepancy between load1 and load2 too large) and ua45 (not at "home" position after power-on/restart) error messages on the reported event date.However, ua07 is unrelated to the reported complaint.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.The autopulse user guide instructs to clear (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.Ua07 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 ua.Following service, the autopulse was subjected to a 10 minutes run-in test using the 95% patient large resuscitation test fixture (lrtf) without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.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 serial number 33696.

Event Description

As reported, during deployment, the autopulse platform (sn (b)(4)) displayed ua45 (not at "home" position after power-on/restart) error message.The call was for cardiac arrest patient.The user attempted to troubleshoot by setting the platform back to home position, but was unable to clear the ua45 error message.No known impact or patient consequence information was available.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 8232770
• MDR Text Key: 132579583
• Report Number: 3010617000-2018-01288
• 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: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• 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: 12/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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