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

Model Number MODEL 100

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Pneumonia (2011); Pneumothorax (2012); Complaint, Ill-Defined (2331); Respiratory Failure (2484)

Event Date 11/28/2014

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, a (b)(6) year old male, (b)(6), with an underlying condition of hyperkalaemia and dependence on renal dialysis was hospitalized as a result of complications from pneumonia.The cardiac arrest was witnessed and occurred at the hospital icu, where the patient was being monitored by hospital telemetry.Manual cpr was administered for approximately 10 minutes.The patient was intubated and administered adrenaline.Radiographic imaging was performed per hospital protocol.The autopulse was deployed without any issues and ran for approximately 40 minutes.Use of the autopulse was continued until the patient's family arrived at the hospital.Rosc (return of spontaneous circulation) was not achieved.The physician pronounced the patient.The cause of death was due to respiratory failure.An autopsy was performed, however a copy of the report will not be provided.The physician indicated that the relationship between use of the autopulse and the pneumothorax is unknown.He added however, that manual cpr may have contributed to this.No further information was provided.

Manufacturer Narrative

Product in complaint will not be returned.Therefore, physical investigation cannot be performed.A supplemental report will be filed if the product in complaint is returned and investigation is completed.Information received from the customer indicated rosc was never achieved with either manual or mechanical compression.Based on the follow-up information, the customer did not report any device malfunction.The platform performed successful compressions for 40 minutes.Typically, the functional time of the platform with a fully charged battery is 30 minutes.In addition, the customer did not attribute patient's death to the autopulse device.Pneumothorax is likely with manual cpr as well as with 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 injury.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 2.7% for pneumothorax.

• 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: 4362774
• MDR Text Key: 5236147
• Report Number: 3010617000-2014-00667
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-700-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2014
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2012
• 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): Other
• Patient Age: 77 YR
• Patient Weight: 41