FDA Adverse Event
Malfunction
Summary report: N
TRIOLOGY 100`
MDR report key: 4113645
·
Received September 17, 2014
Report
- Report Number
- 2518422-2014-01605
- Event Type
- Malfunction
- Date Received
- September 17, 2014
- Date of Event
- August 21, 2014
- Report Date
- August 21, 2014
- Manufacturer
- RESPIRONICS INC.,
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. OTHER: THE DEVICE WAS REPAIRED BUT NOT RETURNED TO THE CUSTOMER, PENDING CUSTOMER APPROVAL OF THE ESTIMATE.
Description of Event or Problem · 1
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576080 | TRIOLOGY 100` | CBK | RESPIRONICS INC., | 1054096 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |