FDA Adverse Event
Death
Summary report: N
VISTA XL
MDR report key: 3853647
·
Received May 29, 2014
Report
- Report Number
- 1220063-2014-00020
- Event Type
- Death
- Date Received
- May 29, 2014
- Date of Event
- April 27, 2014
- Report Date
- May 4, 2014
- Manufacturer
- DRAEGER MEDICAL SYSTEMS, INC.
- Product Code
- MHX
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DRAEGER IS STILL INVESTIGATION THE REPORTED INCIDENT. A F/U REPORT WILL BE SUBMITTED AS SOON AS THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DOCTOR (B)(6) FROM (B)(6) HOSPITAL-MEDINAH NICU DEPARTMENT, WHO OBSERVED THIS CASE, SAID THAT HE HAD PATIENT CONNECTED WITH INFINITY VISTA XL MONITOR (SPO2 SENSOR ONLY). THE PATIENT WAS DEAD, BUT THE O2 SATURATION STILL APPEARED ON THE MONITOR. DRAEGER REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 317339 | VISTA XL | PATIENT MONITOR | MHX | DRAEGER MEDICAL SYSTEMS, INC. | MS18986 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death | NO |