MAUDE Adverse Event Report: COVIDIEN DAR; HEATED MOISTURE EXCHANGER

Model Number 352/5877

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 04/05/2015

Event Type  Death  

Event Description

It was reported that one day after a new heated moisture exchanger (hme) was placed, the patient died.Patient was an (b)(6) year old male, hospitalized with a cerebral infarction and pneumonia.Customer also reported that the patient's death is not verified in regards to the hme and that there is a possibility that the ventilator volume declined and hastened the death.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Covidien/medtronic reference number (b)(4).

• Brand Name: DAR
• Type of Device: HEATED MOISTURE EXCHANGER
• Manufacturer (Section D): COVIDIEN; via bove, 2; i-41037; mirandola ; IT
• Manufacturer (Section G): MIRANDOLA-RX; via bove, 2; i-41037; mirandola ; IT
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4769959
• MDR Text Key: 21838240
• Report Number: 2936999-2015-00438
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K941381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 352/5877
• Device Catalogue Number: 352/5877
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 84 YR