MAUDE Adverse Event Report: UNKNOWN UNKNOWN; CARDIAC CHEST COMPRESSOR

Model Number UNKNOWN

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

Patient Problems Cardiac Arrest (1762); Bone Fracture(s) (1870); Injury (2348)

Event Type  Injury  

Event Description

During a follow up for additional information regarding mfr.Report 3010617000-2015-00105, it was reported through second hand information from the attending nurse that two additional patients were treated for cardiac arrest with mechanical cpr and sustained the same amount of trauma as the patient reported under mfr.Report 3010617000-2015-00105 (the patient had rib fractures and trauma to the patient's chest.) these events occurred within a few days of each other.No specific details were provided and it is unknown if the autopulse platform was used during these two events.Manufacturer has made good faith efforts to obtain clarification and further information.The customer was contacted via e-mail on (b)(6) 2015.However, no additional information has been provided.Manufacturer is unable to confirm the following: 1.Whether the events actually occurred.2.Whether the zoll device or a competitor device was used.This report is being submitted by the manufacturer due to reports of rib injuries sustained during mechanical cpr with an unknown device.

Manufacturer Narrative

It is unknown if any manual cpr was performed.Rib fracture can be caused by manual cpr as well as with the mechanical cpr.Based on the information that is currently available, the connection of the reported injury to the device can neither be confirmed or ruled out.According to 11 different published reports, standard manual cpr complications occur at rates of 33% for rib fracture, which are comparable to rates with use of autopulse.It is unknown if the autopulse platform was used during the reported events.A supplemental report will be filed if the manufacturer receives additional clarification or information regarding the two patient events.

• Brand Name: UNKNOWN
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): UNKNOWN
• 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: 4555540
• MDR Text Key: 5479169
• Report Number: 3010617000-2015-00120
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• 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