MAUDE Adverse Event Report: H AND S MANUFACTURING SERVICES LLC CARDIOQUIP; COOLER HEATER

Model Number MCH-1000(M)

Device Problems Device Emits Odor (1425); Shipping Damage or Problem (1570)

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

Event Date 01/20/2016

Event Type  malfunction  

Event Description

The customer had called reporting the unit was not working properly, and that the nurse noted a "smell of smoke".The customer was sent a new unit, the unit in question was investigated and was found to have shipping damage.Upon further inspection of the unit, the manufacturer was unable to produce either the smell or the appearance of smoke from the unit.

• Brand Name: CARDIOQUIP
• Type of Device: COOLER HEATER
• Manufacturer (Section D): H AND S MANUFACTURING SERVICES LLC
• MDR Report Key: 6386907
• MDR Text Key: 69482967
• Report Number: MW5068335
• Device Sequence Number: 1
• Product Code: DWC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000(M)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1