FDA Adverse Event
Other
Summary report: N
MILLENNIUM INFANT VENTILATOR
MDR report key: 2509511
·
Received March 23, 2012
Report
- Report Number
- 2020676-2012-00011
- Event Type
- Other
- Date Received
- March 23, 2012
- Date of Event
- February 24, 2012
- Report Date
- March 23, 2012
- Manufacturer
- SECHRIST INDUSTRIES, INC.
- Product Code
- CBK
- PMA / PMN Number
- K993167
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE LANGUAGE WAS RESET USING INSTRUCTIONS PROVIDED BY SERVICE MANUAL. DEVICE WILL NOT BE RETURNED SINCE THIS WAS CORRECTED BY DISTRIBUTOR PRIOR TO USE.
Description of Event or Problem · 1
THIS REPORT IS SUBMITTED TO COMPLY WITH MDR MALFUNCTION NOTICE 76 FR 12473 REQUIRING THE REPORTED OF INCIDENTS INVOLVING A LIFE-SUPPORTING AND/OR LIFE-SUSTAINING DEVICE. CUSTOMER REPORTED DISPLAYED LANGUAGE IS NOT IN (B)(6). CUSTOMER REPORTED NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MILLENNIUM INFANT VENTILATOR | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | SECHRIST INDUSTRIES, INC. | 23065-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |