FDA Adverse Event
Other
Summary report: N
HT70 VENTILATOR
MDR report key: 2181536
·
Received July 15, 2011
Report
- Report Number
- 2023050-2011-00031
- Event Type
- Other
- Date Received
- July 15, 2011
- Date of Event
- June 24, 2011
- Report Date
- June 24, 2011
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CE
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REPORTEDLY, THE DISPLAY OF THE VENTILATOR DISAPPEARED WITH ONLY A WHITE FLICKERING LINE ON THE DISPLAY SCREEN WHILE A PT WAS BEING VENTILATED AND TRANSPORTED TO ANOTHER HOSPITAL. AS A RESULT OF THE BLANK DISPLAY SCREEN, THE PT WAS AMBU BAGGED, SWITCHED TO A HOSP VENTILATOR AND WAS READMITTED BACK TO THE HOSP THEY HAD JUST LEFT. PLEASE NOTE THAT THE VENTILATOR CONTINUED TO VENTILATE DURING THIS EVENT AND THERE WAS NO PERMANENT PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |