MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE 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

A (b)(6) year old male collapsed at work - no apparent injury from fall.Co-workers began manual cpr.The zoll autopulse mechanical cpr device was applied by paramedics upon their arrival.The pt was subsequently intubated with blood noted in et tube, enroute to hospital, the pt's tidal volumed dropped despite ventilation and his face and eyes began to swell significantly and turned cyanotic.Upon arrival to the er, the autopulse was removed and manual cpr initiated.However, staff performing cpr stated that the chest was concave and "mushy".A large amount of subcutaneous emphysema and distention was noted in the neck and face.The pt expired at 10:58 (arrived in er at 10:44).The pt's body was transferred to unity point (b)(6) for autopsy (coroner's case).Note: according to the paramedics documentation at the time of their arrival at the pt's workplace, "the autopulse strap was initially applied approximately 1 inch lower than the desired position as the autopulse was started and the strap had to be readjusted after delivering two compressions".

• Brand Name: AUTOPULSE RESUSCITATION SYSTEM
• Type of Device: AUTOPULSE RESUSCITATION SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION; 650 almanor ave; sunnyvale CA 94085
• MDR Report Key: 3883985
• MDR Text Key: 17577361
• Report Number: 3883985
• Device Sequence Number: 1
• Product Code: DRM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• 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
• 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 LIFEBAND LOAD - DISTRIBUTING BAND
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Weight: 113