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

Model Number MODEL 100

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the user noticed that the autopulse platform (sn (b)(4)) handle at the front enclosure got separated and noticed a screw inside the platform" was confirmed during the visual inspection.The root cause for the physical damage was appeared to be the characteristics of mishandling.The autopulse platform was manufactured in 2009 and is more than 10 years old, past the expected service life of 5 years.The last service was performed on february 2019 and both the front and bottom enclosures were replaced.Upon visual inspection, noticed chipped or broken screw well on the front enclosure, which caused the handle to get separate, thus confirming the reported complaint.No other physical damage was observed.The front enclosure was replaced to address the physical damage.The autopulse platform passed the initial functional testing without any fault or error.Upon further investigation, observed rattling sound from the bearing caused by defective encoder, likely due to normal wear and tear of the autopulse platform.The observed defect is unrelated to the reported complaint.The encoder gearbox was replaced to address the rattling sound.The archive data review showed occurrence of multiple user advisory's (ua) 02 (compression tracking error), ua17 (max motor on time exceeded during active operation), fault 27 (encoder fault), fault 34 (encoder failure) and ua 45 (not at "home" position after power-on/restart) error messages around the reported event date.All these error messages were cleared by the customer and the platform performed 478 compressions with normal exit.The observed error messages were unrelated to the reported complaint.Fault 27 and 34 are related to the defective encoder.Therefore, the probable root cause for these two faults could be due to intermittent problem with the encoder.User advisory is a clearable error message, ua02 is an indication that the autopulse has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both the patient and the band are properly aligned, and press restart.Ua17 is an indication that the lifeband is twisted or battery voltage is low.The recommended actions to take for this type of user advisory are: open lifeband, start manual cpr, check battery and lifeband, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.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 ua45 will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a 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.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse platform with sn (b)(4).(b)(4) was reported on february 01, 2019 and front enclosure was replaced to address the physical damage.

Event Description

During device check, the user noticed that the autopulse platform (sn (b)(4)) handle at the front enclosure got separated and noticed a screw inside the platform.No patient involvement.During investigation on (b)(6) 2020, observed rattling sound from the autopulse platform due to defective encoder.

• 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: 10041020
• MDR Text Key: 193943859
• Report Number: 3010617000-2020-00446
• 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: 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• 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: 04/07/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2009
• 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