MAUDE Adverse Event Report: MALLINCKRODT WARMTOUCH COMPACT WARMING UNIT; SYSTEM, THERMAL REGULATING

Model Number 501-5200

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2017

Event Type  malfunction  

Event Description

Medtronic received communication alleging that during use, the flow stopped with black smoke.There is no allegation of patient harm with this device.

Manufacturer Narrative

Evaluation summary: without the actual complaint sample a full investigation cannot be carried out therefore we are unable to determine the cause for this specific event.Manufacturing controls are in place to detect cuff inflation/deflation defects to reduce the potential for occurrence during the manufacturing process.Correction: last name, phone#), (name, email).If information is provided in the future, a supplemental report will be issued.

• Brand Name: WARMTOUCH COMPACT WARMING UNIT
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): MALLINCKRODT; 2111 east galbraith rd. ; cincinnati OH 45237
• Manufacturer (Section G): MALLINCKRODT; 2111 east galbraith rd. ; cincinnati OH 45237
• Manufacturer Contact: avi kluger ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 6828638
• MDR Text Key: 83939246
• Report Number: 2936999-2017-05433
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K913016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 501-5200
• Device Catalogue Number: 501-5200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1