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 07/24/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4)) displayed error message was confirmed during the archive data review but not during the functional testing.There were no device deficiencies found during the evaluation of the returned platform that could have caused or contributed to the reported complaint.The probable root cause for the reported complaint is most likely attributed to user error.During the visual inspection, cracked top cover on the returned autopulse platform was observed, unrelated to the reported complaint.This type of physical damage was likely attributed to mishandling such as a drop.The top cover needs to be replaced to address the physical damage.The autopulse platform passed the initial functional testing without any fault or error.The archive data review showed the occurrence of multiple user advisory (ua) 18 (max take-up revolution exceeded), ua 02 (compression tracking error), ua17 (max motor on time exceeded during active operation), fault 27 (encoder fault), 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.Fault 27 is related to the defective encoder.The encoder may have had some intermittent technical problems that could not be directly identified during the functional testing.As a precautionary measure, the encoder gearbox was replaced.User advisory is a clearable error message, the ua 18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.The ua 02 is an indication that the autopulse platform 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.The ua 17 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 platform is powered on, a ua 45 will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a ua 45 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 autopulse platform passed the final testing without any fault or error.

Event Description

During the patient use, the autopulse platform displayed an unknown user advisory.Per the reporter, there was no adverse impact to the patient and no additional information was provided.No consequences or impact to patient.

• 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: 10423971
• MDR Text Key: 204217213
• Report Number: 3010617000-2020-00796
• 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: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• 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: 07/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2015
• 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