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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem Not Applicable (3189)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet 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.The event described in this mdr also occurred on the following day ((b)(6) 2015) on s/n (b)(4) and is being reported in mfr # 3010617000-2015-00687 (for ccr (b)(4)).

Event Description

Customer reported that during patient use, the autopulse platform s/n (b)(4) would only partially retract and the message of "realign patient" displayed.Summary of event: on (b)(6) 2015 at 8:50 am the ems were called to a residence on an (b)(6) male, who had suffered cardiac arrest, which was witnessed.Witness stated that the patient went into cardiac arrest at 8:13 am.The local fire department were the first responders.There was no bystander cpr performed.The first responders performed manual cpr starting at 8:20 am, until the ems arrived and started to set up the autopulse for compressions at 8:50 am.There was a 30 second delay from manual cpr to the patient being placed on the autopulse platform to start compressions.The ems had difficulty starting the autopulse.Upon power up they received the error message to "realign the patient." they realigned the patient on the autopulse and restarted the device.The first autopulse compression started at 8:55 am.Compressions were administered for 20 minutes, after which time the patient was placed on a backboard, into the ambulance and transported to the hospital.At some point (not provided when) they got an error to realign patient and restart the device.They were able to resolve and clear the error code, which took them less than 1 minute.No manual cpr was administered during that time.The patient did not achieve rosc (return of spontaneous circulation) and later that morning expired in the hospital.The patient's had a history of asthma, hypertension, and high cholesterol.The medications taken by the patient were: allopurinol, aspirin, gabapentin, loratadine, flunisolide, proverntil, ranitidine, and terazonsin.The autopulse was checked daily by the ems supervisor.They check the lifebands, replace the battery and power the autopulse on and off checking for any error messages.On (b)(6) 2015 there were no issues during shift check.There was no additional and patient information provided.

Manufacturer Narrative

The autopulse platform was returned to zoll for investigation on (b)(4) 2015.Visual inspection of the returned platform was performed; front cover was cracked and load plate cover was noted to be defective.The autopulse platform is a reusable device and was manufactured on 02/17/2009.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device and not related to the reported complaint of the autopulse displaying "realign patient" message.A review of the archive was performed and multiple faults were noted on the date of the events (b)(4) 2015.User advisory (ua) 07 (discrepancy between load 1 and load 2 too large) and ua 2 (compression tracking error).It was not possible to perform functional testing on the device as the drive train motor brake gap was too tight.In summary the customer's reported complaint is confirmed.The root cause for the reported complaint is the load imbalance between left and right sides of the load plate.In this incident it is possible that the patient was not placed on device correctly or patient was possibly moving on the board during compression.Load cell characterization testing was also performed, and confirmed that both load cell modules are functioning within the specification.A brake gap inspection was performed and verified that the brake gap was out of the specification which is unrelated to the reported complaint.The break gap was adjusted back within the specification.The functional test was performed using the 95% patient test fixture (lrtf) for several hours, and did not duplicate any of the user advisory or fault.It should be noted that autopulse is adjunct to manual cpr.In case of stoppage of autopulse the user reverts to manual cpr.If an autopulse unexpectedly stops compressions, it is not likely to cause or contribute to a patient death or serious injury.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5312303
• MDR Text Key: 33925928
• Report Number: 3010617000-2015-00688
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2009
• 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
• Patient Age: 84 YR
• Patient Weight: 91