MAUDE Adverse Event Report: HALYARD HEALTH CONTROL UNIT MODEL 1000; PATIENT WARMING DEVICE

Model Number 01000-01

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Manufacturer Narrative

(b)(4).This complaint is a follow-up to report number 1033422-2014-00025 filed under the (b)(4) healthcare registration.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The root cause could not be determined.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).

Event Description

A review of the maude database identified the following event."the patient has multiple blisters on left upper back from the (b)(4) warming pads used in the or.One blister broke and then others as well.The wound has extended to skin tears around the blister areas.This skin ulcer was most likely caused by a combination of a pressure device behind his back in the operating room for positioning as well as a heating blanket.Wound nurse consulted.".

• Brand Name: CONTROL UNIT MODEL 1000
• Type of Device: PATIENT WARMING DEVICE
• Manufacturer (Section D): HALYARD HEALTH; 5405 windward parkway; 5405 windward parkway GA 30004
• Manufacturer (Section G): MEDIVANCE, INC.; 321 south taylor avenue; suite 200; louisville CO 80027
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5817703
• MDR Text Key: 50295754
• Report Number: 3011270181-2016-00013
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 01000-01
• Device Catalogue Number: 991094765
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention