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

Model Number MODEL 100

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

Patient Problems Bone Fracture(s) (1870); Liver Laceration(s) (1955); Injury (2348)

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform for investigation.A supplemental report will be filed when the product is returned and the investigation has been completed.

Event Description

As published in the journal of the japanese society of intensive care medicine, a (b)(6) female was transferred to the hospital with respiratory distress, and suffered a cardiac arrest (ca) after the arrival.Per physician, the ca was caused by a pulmonary thromboembolism.The physicians immediately started cpr using the autopulse platform.Although the patient's hemodynamics were well maintained following the return of spontaneous circulation, they suddenly became unstable 15 hours after her admission to the icu.Then, progressive anemia was detected.Abdominal ultrasonography and ct revealed injuries to the liver and spleen and multiple rib fractures; hence the physicians diagnosed the patient with hypovolemic shock.The physicians performed splenectomy and coagulative hemostasis for the liver laceration.It was suggested that the shifting of the lifeband to the caudal side due to the patient's obesity (bmi 38kg/m2), might have caused these complications.When using mechanical chest compression devices, clinicians should be familiar with its characteristics, and must take care to avoid complications.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 8440653
• MDR Text Key: 139695368
• Report Number: 3010617000-2019-00225
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• 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: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2019

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?: 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
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/21/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 73 YR