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 Patient Involvement (2645)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4)) drive shaft got stuck and displayed user advisory - "(ua) 45" (not at "home" position after power-on/restart) was not confirmed during functional testing but confirm during archive data review.The functional testing on the returned autopulse platform passed without any fault or error and lifeband could be pulled up.The drive shaft was able to be rotated freely and the returned autopulse platform performed as intended.No physical damage was observed on the returned autopulse platform during visual inspection.During archive data review, multiple ua45 were recorded on the reported event date, thus, confirming the reported complaint.Also recorded in the archive, user advisory - ua2 (compression tracking error) and ua20 (drive shaft out of range).Ua2 was not related to the reported complaint and was cleared by the user.Ua20 is related to the reported complaint, if the user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message is not resolved properly, it leads to (ua) 20 because the drive shaft is not restored at the home position.Note that user advisory error messages are designed into the platform when one of several conditions is detected.Per the autopulse resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on.A user advisory - (ua) 45 will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory - ua45, pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.Ua20 error message alerts when the drive shaft is not within the specified range of positions.This can be cleared by returning the drive shaft to home position using the administrative menu.User advisory is a clearable error message, ua02 error message alerts the operator as the drive shaft rotates and shortens/tightens the life band (compresses the chest), and the load sensors do not see the expected increase in load.This typically occurs if the patient is misaligned on the platform or the life band is opened or in the incorrect position during take up/compression or the lifeband is opened or in the incorrect position during take-up/compression.Clear the ua by pressing the restart button.After service completion, 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 load cell characterization test passed.The autopulse platform passed all functional tests.

Event Description

During customer training by zoll representative, the drive shaft on the autopulse platform (serial # (b)(4)) got stuck and displayed a user advisory - "(ua) 45" (driveshaft not at "home" position after power-on/restart) error message.Per customer, the lifeband could not be pulled up from the platform.No patient involvement.

• 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: 10281132
• MDR Text Key: 199104812
• Report Number: 3010617000-2020-00695
• 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: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 07/01/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2020
• 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