MAUDE Adverse Event Report: OSSUR AMERICAS, INC. RESOLVE HALO VEST SHORT LAMSWOOL; COMPONENT, TRACTION, NON-INVASIVE

Model Number 545700L

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The vest currently provides instructions for emergency access to the chest as shown in the photo attached.Further details will be gathered from the hospital and we will provide a follow up report.

Event Description

Patient was wearing halo vest and required emergency cpr.The staff did not know the correct procedure to remove the vest to administer cpr.The patient died.

Manufacturer Narrative

The vest currently provides instructions for emergency access to the chest as shown in the photo attached.We have initiated a preventative action to maximize the visibility of the emergency label and/or change the labels to symbols rather than text.-.

Event Description

Patient was wearing halo vest and required emergency cpr.The staff did not know the correct procedure to remove the vest to administer cpr.The patient died.

• Brand Name: RESOLVE HALO VEST SHORT LAMSWOOL
• Type of Device: COMPONENT, TRACTION, NON-INVASIVE
• Manufacturer (Section D): OSSUR AMERICAS, INC.; 910 burstein drive; albion MI 49224
• Manufacturer (Section G): OSSUR AMERICAS, INC.; 910 burstein drive; albion MI 49224
• Manufacturer Contact: karen montes ; 27051 towne centre drive; foothill ranch, CA 92610 ; 9493823741
• MDR Report Key: 5513714
• MDR Text Key: 40772809
• Report Number: 1836248-2016-00002
• Device Sequence Number: 1
• Product Code: KQZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Paramedic
• Device Model Number: 545700L
• Device Catalogue Number: 545700L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death