FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 2770291
·
Received September 28, 2012
Report
- Report Number
- 2023050-2012-00187
- Event Type
- Injury
- Date Received
- September 28, 2012
- Date of Event
- August 20, 2012
- Report Date
- August 31, 2012
- Manufacturer
- NEWPORT MEDICAL INSTRUMENT
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THOUGH REQUESTED, PT INFO WAS NOT PROVIDED.
Description of Event or Problem · 1
REPORTEDLY, DURING PT USE, UPON CONNECTING THE AC CABLE TO THE VENTILATOR, THE EXTERNAL POWER LED DID NOT LIGHT. THERE WAS A "SWITCHED TO BACKUP BATTERY" ALARM. THE ISSUE WAS RESOLVED WHEN THE POWER PAC BATTERY WAS REMOVED AND RE-INSERTED SEVERAL TIMES. LATER, THE PT WAS MANUALLY VENTILATED BEFORE BEING SWITCHED TO ANOTHER VENTILATOR. THERE WERE NO ADVERSE PT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENT | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |