FDA Adverse Event
Death
Summary report: N
CADENCE
MDR report key: 2587954
·
Received May 24, 2012
Report
- Report Number
- 2031642-2012-00227
- Event Type
- Death
- Date Received
- May 24, 2012
- Date of Event
- November 2, 2009
- Report Date
- April 25, 2012
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- BZR
- PMA / PMN Number
- K050381
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
NO DEVICE MALFUNCTION. NO DEVICE MALFUNCTION.
Description of Event or Problem · 1
AN ATTORNEY REPRESENTING (B)(6), CONTACTED A COMPANY ASSOCIATE REGARDING A LEGAL COMPLAINT. THE LEGAL COMPLAINT ALLEGES A MALE PATIENT DIED (B)(6) 2009, DURING HOSPITALIZATION AT THE FACILITY DUE TO NEGLIGENCE. THE ATTORNEY REPORTED THAT THE HOSPITAL DID NOT CONTACT ANYONE TO REPORT THE PATIENT DEATH EVENT AT THE TIME IT OCCURRED AND THAT THE HOSPITAL DID NOT FILE A MEDICAL DEVICE REPORT WITH THE FDA. THE COMPLAINT ALLEGES THAT THE HOSPITAL STAFF PROVIDED IMPROPER CARE AND SHOULD HAVE PUT THE PATIENT ON CONVENTIONAL VENTILATION AND THERE IS NO ALLEGATION IN THE COMPLAINT THAT THIS DEVICE MALFUNCTIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CADENCE | TRANSTRACHEAL CONTINUOUS FLOW GAS DELIVERY SYSTEM | BZR | RESPIRONICS CALIFORNIA, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |