MAUDE Adverse Event Report: ZOLL CIRCULATION AUTO PULSE PLATFORM RESUSCITATION SYSTEM

Model Number 100 PLATEFORM

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Pneumothorax (2012)

Event Date 05/30/2014

Event Type  Death  

Event Description

(b)(6) paramedics received a 911 call that a man had collapsed at work.Bystander cpr was initiated.Fire department took over cpr upon their arrival.When (b)(6) paramedics arrived, the fire department was performing cpr.The (b)(6) paramedics applied auto pulse resuscitation system upon arrival at the scene.Auto pulse had to be repositioned after two compressions as the band slid 1 inch from proper positioning.Et tube was placed with blood in tube upon intubation and a small amount of blood was noted in airway prior to intubation.Thick rhonchi upon auscultation.Initial end tidal co2 was 24.Despite use of auto pulse, the end tidal co2 fell to 4.Bilateral lung fields were reassessed and lung sounds remained unchanged.A few minutes later, the pt's eyes and face began to swell.Neck and face became cyanotic.Had sub q air in face.Upon arrival at the emergency department, the auto pulse was discontinued and manual compressions were performed by emergency room staff.Emergency room staff reported that patient's chest was concave and mushy.Patient arrived in ed at 10:44 am and was pronounced dead at 10:58 am.(b)(6) paramedics documentation stated that patient had history of htn as provided by co-worker.

• Brand Name: AUTO PULSE PLATFORM RESUSCITATION SYSTEM
• Type of Device: AUTO PULSE
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 3906318
• MDR Text Key: 4674285
• Report Number: 3906318
• Device Sequence Number: 1
• Product Code: DRM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/10/2014,06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100 PLATEFORM
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2014
• Distributor Facility Aware Date: 05/30/2014
• Event Location: Other
• Date Report to Manufacturer: 06/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZOLL LIFE BAND LOAD - DISTRIBUTING BAND
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Weight: 113