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 04/30/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event on the autopulse platform (sn (b)(4)) displayed "pull up lifeband and press restart" message was confirmed during the initial functional testing and archive review.The cause for the reported complaint based on the archive data review was due to user advisory (ua) 45 (not at "home" position after power-on/restart) error message" upon powering on.The root cause for the ua45 error message was due to the driveshaft not being at home position which is likely attributed to user error.User advisory is a clearable error message, ua45 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 instruction, to clear ua45, 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.Unrelated to the reported complaint, cracked top cover and front enclosure were observed during visual inspection.Root cause were likely attributed to mishandling such as a drop.During archive data review, multiple ua 45 error messages were observed.During functional testing, the autopulse platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message" upon powering on.The root cause for the ua45 error message was due to the driveshaft not being at home position.Using the administrative menu, the driveshaft was readjusted back to home position.After clearing the ua45 error message, the autopulse platform performed compressions without any fault or error using lrtf (large resuscitation test fixture).After replacing top cover and front enclosure, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical records were reviewed for service information related to the reported complaint and there was no similar history of complaint reported for autopulse with serial number (b)(4).

Event Description

The autopulse platform (sn (b)(4)) displayed "pull up lifeband and press restart" message.The user was unable to clear the message.Patient use information was requested but no additional information was provided, therefore patient use is unknown.

• 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: 10089256
• MDR Text Key: 193116424
• Report Number: 3010617000-2020-00539
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2013
• 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