MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO MISTRAL-AIR BLOWER, SYK; SYSTEM, THERMAL REGULATING

Catalog Number MA1200-PM

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 12/12/2018

Event Type  malfunction  

Event Description

It was reported that allegedly patients are feeling an electric shock from the device.Medical intervention was not reported.

Event Description

It was reported that allegedly patients are feeling an electric shock from the device.Medical intervention was not reported.

Manufacturer Narrative

It was reported to stryker that patients are feeling an "electric shock" from the ma1200-pm blower.It was later clarified that the patient experienced a static shock during use with the ma3320-pm blankets.It was determined that the mistral air blower reported in the complaint is a concomitant product to the blanket.The patient was not adversely affected and no clinically relevant delay in treatment was reported.

• Brand Name: MISTRAL-AIR BLOWER, SYK
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• MDR Report Key: 8224064
• MDR Text Key: 132534374
• Report Number: 3003312341-2019-00001
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• PMA/PMN Number: K101705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: MA1200-PM
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MA3320-PM BLANKET