MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Event Description

The customer reported that the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message during the device test with the manikin.The user installed new lifeband and repositioned the manikin, however, was unable to clear the error message.No patient involvement.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(6)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message" was confirmed during the functional testing and on the archive data review.The root cause for user advisory (ua) 07 was due to defective load cells.The defective load cells were likely attributed to mishandling such as a drop or a defective component.Upon visual inspection, unrelated to the reported complaint, a cut patient head restraint wires were observed.This type of physical damage is likely due to mishandling, the patient head restraint wires could have been cut to free the patient from the platform or the user could have been lifting the platform by holding the head restraints.Both front and bottom covers of the platform were removed and corroded top blue case cover metalized coating due to fluid ingresses was observed, unrelated to the reported complaint.The top cover was replaced to address the issue and the platform required a bio-cleaning.The autopulse platform is a reusable device.The root cause is likely attributed to user mishandling as no preventive maintenance was performed since 2014.Also, unrelated to the reported complaint, during visual inspection noticed several screws were missing from the platform's cover and it was noted that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance.The clutch plate was deburred to address the sticky clutch problem.The cause for the observed missing screws and the sticky clutch problem was due to normal wear and tear.The autopulse platform was manufactured in (b)(6) 2011 and is more than 9 years old, beyond the expected service life of 5 years.Per autopulse user guide, 4.2.Cleaning the autopulse platform section: "wipe all the surfaces of the autopulse platform free of foreign matter and spills with a disinfectant or bactericidal wipe.Check the vents to ensure that they are free and clear of any obstructive matter.Caution: do not submerge the autopulse in liquid.Ensure that the autopulse is dry before storing." the initial functional testing of the autopulse platform could not be performed due to user advisory (ua) 07 error message displayed upon powering on, thus confirming the customer complaint.Review of the archive data indicated error message user advisory (ua) 07 on the customer reported event date.The load cell characterization test revealed that both load cells were over-reporting.The defective load cells were replaced to address the error.Following service, the autopulse platform was subjected to 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.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse with serial number 40488.Ccr 16483, reported on may 20, 2014, the defective load cells were replaced to clear the error.

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10492867
• MDR Text Key: 205653869
• Report Number: 3010617000-2020-00861
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• 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: 09/08/2020
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1