FDA Adverse Event Injury Summary report: N

MPV, 7200SPE, W/PSV

MDR report key: 1119024 · Received August 15, 2008

Report

Report Number
2024500-2008-00037
Event Type
Injury
Date Received
August 15, 2008
Report Date
July 16, 2008
Manufacturer
CARLSBAD-RX
Product Code
CBK
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
BR
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER HAS BEEN CONTACTED TO OBTAIN FURTHER INFORMATION AND AT THIS TIME NO NEW INFORMATION HAS BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN NEW INFORMATION IS RECEIVED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE EXHALATION VALVE AND THE SECURITY VALVE DID NOT OPEN AND THAT 'BAROTRAUMA' OCCURRED IN THE PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MPV, 7200SPE, W/PSV NONE CBK CARLSBAD-RX 7200SPE

Patients

Seq Age Sex Outcome Treatment
1 Required Intervention