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 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) displaying a user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message was confirmed during functional testing and confirmed during archive data review.The investigation findings revealed that the root cause was due to the driveshaft not to be at home position in which likely attributed to user error.Visual inspection of the returned platform was performed and found no physical damage.The archive data was reviewed and contained multiple user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message occurred on the reported event date.Evaluation of the platform during initial power up, revealed a ua 45 error message on the user control panel.It was indicated that the driveshaft was not in home position.The driveshaft was readjusted back to home position.The 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 platform passed all functional tests and is ready for clinical use.Note ua 45 alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.This user advisory will persist until the driveshaft is returned to its home position.Per the autopulse user guide instruct, to clear ua 45, the operator needs to pull up the lifeband until the chest bands are full extended.This action will move the driveshaft to its home position.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 patient use, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message on the user control panel.The crew was unable to clear ua 45 error message.The crew immediately performed manual cpr.No known impact or patient consequence was reported.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 9537002
• MDR Text Key: 179429685
• Report Number: 3010617000-2019-01202
• 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: 12/30/2019

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: 12/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• 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