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

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Bone Fracture(s) (1870); Pneumothorax (2012)

Event Date 12/08/2014

Event Type  Injury  

Event Description

On (b)(6), a call came in for an (b)(6) male patient who was in a special nursing home for the aged, as he suffered a cardiac arrest.Patient had a history of dementia, subdural hematoma and aspiration pneumonia.The cardiac arrest was witnessed by the nursing home staff.Emergency services were notified and the patient was transported to (b)(6) medical center.Between the staff and ems crew who transported the patient to the hospital, manual cpr was performed for approximately 30 minutes.Upon arrival at the hospital at 9:08, the er staff switched to mechanical cpr using the autopulse.The autopulse was deployed without any issues.After 28 minutes of successful autopulse compressions, the patient achieved rosc.The physician inserted a central venous catheter by using x-ray.The x-ray revealed that the patient had precordial fracture and pneumothorax.The physician performed chest drainage for the pneumothorax.The next day, on (b)(6), the patient passed away.Per treating physician, the autopulse was functional and no issues were encountered.Physician indicated that the patient had an anterior fracture which could have caused the pneumothorax.Pneumothorax may have also occurred during tracheal intubation, cv insertion or during manual or mechanical cpr.The patient also had a thoracic deformity, which put him at a higher risk for fractures to occur.Per physician, the pneumothorax and precordial fracture were caused by cpr.The cause of death was from progression of primary disease and was not attributed to the use of autopulse.No further information was provided.

Manufacturer Narrative

Zoll has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.Information received from the customer indicated the patient had achieved rosc after manual or mechanical compression.Per the physician, the autopulse platform was functional and did not report any device malfunction.The cause of death was from the progression of primary disease.The physician did not attribute patient death to the autopulse device.Pneumothorax and pericardial fracture are likely with manual cpr as well as with the mechanical cpr.Since the manual cpr was employed first and the follow-up information does not indicate any malfunction, it is not possible to determine which of the two cpr modalities caused the injuries.However, connection of the reported injury to the device cannot be ruled out.Note: according to 11 different published reports standard manual cpr complications occur at rates of (b)(6) for pneumothorax and (b)(6) for rib fracture.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: 4398850
• MDR Text Key: 5436498
• Report Number: 3010617000-2015-00023
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: MANUAL CPR
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 89 YR
• Patient Weight: 65