FDA Adverse Event
Malfunction
Summary report: N
ATMOS FEES SYSTEM SCOPES FOR BEDSIDE SWALLOW STUDY
MDR report key: 9426196
·
Received December 5, 2019
Report
- Report Number
- MW5091478
- Event Type
- Malfunction
- Date Received
- December 5, 2019
- Date of Event
- October 11, 2019
- Report Date
- December 3, 2019
- Manufacturer
- ATMOS MEDIZIN TECHNIK GMBH & CO. KG
- Product Code
- BTA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DEFICIENT AND INCOMPLETE WITH STERRAD 100NX SERIAL #. (B)(4), CONTRARY TO WHAT THE MANUFACTURER HAS TOLD US ¿COMPANY REFUSES TO TAKE RETURNS. FDA SAFETY REPORT ID (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1215301 | ATMOS FEES SYSTEM SCOPES FOR BEDSIDE SWALLOW STUDY | PUMP, PPORTABLE, ASPIRATION (MANUAL OR POWERED) | BTA | ATMOS MEDIZIN TECHNIK GMBH & CO. KG | 950.0320.0 | ||
| 1215302 | ATMOS FEES SYSTEM SCOPES FOR BEDSIDE SWALLOW STUDY | PUMP, PPORTABLE, ASPIRATION (MANUAL OR POWERED) | BTA | ATMOS MEDIZIN TECHNIK GMBH & CO. KG | |||
| 1215303 | ATMOS FEES SYSTEM SCOPES FOR BEDSIDE SWALLOW STUDY | PUMP, PPORTABLE, ASPIRATION (MANUAL OR POWERED) | BTA | ATMOS MEDIZIN TECHNIK GMBH & CO. KG | |||
| 1215304 | ATMOS FEES SYSTEM SCOPES FOR BEDSIDE SWALLOW STUDY | PUMP, PPORTABLE, ASPIRATION (MANUAL OR POWERED) | BTA | ATMOS MEDIZIN TECHNIK GMBH & CO. KG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |