FDA Adverse Event
Death
Summary report: N
MULTINEX
MDR report key: 59195
·
Received December 10, 1996
Report
- Report Number
- 2221819-1996-00005
- Event Type
- Death
- Date Received
- December 10, 1996
- Date of Event
- August 18, 1996
- Report Date
- December 10, 1996
- Manufacturer
- DATASCOPE CORPORATION
- Product Code
- CCL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
WHILE IN USE ON A PT THE UNIT DISPLAYED ERRONEOUS AGENT READINGS. THE PT LATER EXPIRED. THE CUSTOMER DOES NOT ATTRIBUTE THE DEATH OF THE DEATH TO THE UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTINEX | GAS ANALYZER | CCL | DATASCOPE CORPORATION | MULTINEX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |