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

Model Number MODEL 100

Device Problem Device Stops Intermittently (1599)

Patient Problem Cardiac Arrest (1762)

Event Date 06/15/2015

Event Type  malfunction  

Manufacturer Narrative

It should be noted that return of spontaneous circulation (rosc) was achieved after installation of a cardiac pacing probe in the cath lab.However, the patient was pronounced dead in the hospital by the physician two weeks after the cardiac arrest.The cause of the cardiac arrest was full av block.The cause of death was post-anoxic encephalopathy.The autopulse platform in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.

Event Description

A (b)(6) male patient was hospitalized in the intensive care unit (icu).It is unknown why the patient was hospitalized.Patient weighed (b)(6).Patient's medical history included: bronchial squamous cell carcinoma, which was treated by pneumonectomy and radiochemotherapy in 1999; spinal metastases, which was operated on in 2002; brain metastases which was treated in 2008; chronic respiratory failure sequelae to pneumonectomy, hypertension, obstructive sleep apnea, heart disease post-chemotherapy hypokinetic, angina treated with nitrates.Patient was taking the following medications: kardegic, carvedilol, lasilis, vimpat, diffu-k, ramipril, discotrine, eupanthol, claforan, rovamycine, flagyl, terlipressine, amiklin, noradrénaline, adrénaline, dobutamine, midazolam, sufentanyl, hémisuccinate d'hydrocortisone.The cardiac arrest occurred in the patient's room.Patient experienced bradycardia, then cardiopulmonary arrest.Patient was asystole despite treatment with catɃholamines.The medical team (doctors and nurse) present in the patient's room immediately initiated manual cpr when the cardiac arrest occurred.The hospital staff then deployed the autopulse platform.There was no interruption in cpr while the autopulse was deployed.Customer indicated that they had trouble installing the autopulse lifeband.Around 1230, the platform performed 4-5 compressions and then stopped and displayed a "check lifeband position" message.The staff repositioned the lifeband and the patient on the platform, then pulled the lifeband completely up and restarted the platform.The platform performed another 4-5 compressions and then stopped again.This occurred several times.Use of the autopulse was then discontinued.The hospital staff reverted back to manual cpr for a total of approximately 35-40 minutes.Patient was taken to the cath lab with manual cpr in progress.The hospital staff then used another automated resuscitation device (the lucas) on the table of the cath lab.Return of spontaneous circulation (rosc) was achieved after installation of a cardiac pacing probe in the cath lab.Patient was given the following medications: adrénaline, atropine, catecholamines at high doses by syringe pump, calcium chloride, magnesium sulfate and filling isotonic saline.Two weeks after the cardiac arrest, on (b)(6) 2015, patient was pronounced dead in the hospital by the physician.An autopsy was not performed.The cause of the cardiac arrest was full av block.The cause of death was post-anoxic encephalopathy.Per the customer's opinion, it is unknown if the patient's death was related to the autopulse.No further information was provided.

• 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: 5012326
• MDR Text Key: 23391831
• Report Number: 3010617000-2015-00460
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001052
• UDI-Public: 00849111001052
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0740-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2010
• 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: 62 YR
• Patient Weight: 90