MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE RESUSCITATION SYSTEM; COMPRESSOR, CARDIAC, EXTERNAL

Device Problem Defective Device (2588)

Patient Problem Cardiac Arrest (1762)

Event Date 09/16/2021

Event Type  Death  

Event Description

Circumstances for the device failure: approximately 10 minutes into a cardiac arrest call we attempted to put the autopulse into use, the patient was placed onto the device, the unit was powered on and the sizing sequence was started.The lifeband and had to be reset two times (the unit states re-start, instructs the user to pull up on lifeband, and then push start again to re-size the band).Once the band was sized appropriately and the start button was pressed, the unit began compressions.The unit performed approximately 3 compressions before a line went across the screen and the unit completely shut down.At this point, manual compressions were resumed, and no further remedial actions were taken, the unit was removed from resuscitative efforts.Physical defects of device: only physical defect present is the slide gate that holds the battery in is broken.Battery seats into device appropriately corrective actions taken: on scene, none.We have attempted to replicate the error, with success.The unit has shut down completely when attached to an appropriate cpr mannequin.The unit has shut down the same way for several different providers and has happened approximately 6 more times since the event during the resuscitation.When the unit shuts down, it has been turned back on with no corrections made, and the unit performs as prescribed.Patient weight and position: patient weight, approx (b)(6), positioned on the device according to the manufacturer's recommendation (right over the outline on the device.) with the lifeband at a 90-degree angle and just over the patient's chest.History of battery charge/rotation: batteries were placed into service on approx 9/1/2021.All three batteries in service were charged prior to being placed into service, and then we rotate them as follows.Each morning at the start of shift the spare battery carried with the unit is placed into the unit, the battery in the unit is placed onto the charger, and then the battery on the charger is placed into the bag as a spare with the unit.Provider familiarity with the device operation: all providers involved in placing the autopulse into service on this event are appropriately trained in its use.Fda safety report id# (b)(4).

• Brand Name: AUTOPULSE RESUSCITATION SYSTEM
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): ZOLL CIRCULATION, INC.
• MDR Report Key: 12539954
• MDR Text Key: 273769797
• Report Number: MW5104219
• Device Sequence Number: 1
• Product Code: DRM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 49 YR
• Patient Weight: 82