FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 2780498
·
Received October 5, 2012
Report
- Report Number
- 2023050-2012-00201
- Event Type
- Injury
- Date Received
- October 5, 2012
- Date of Event
- September 5, 2012
- Report Date
- September 21, 2012
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THOUGH REQUESTED, PATIENT INFORMATION WAS NOT PROVIDED.
Description of Event or Problem · 1
REPORTEDLY, DURING PATIENT USE, A 'CHECK CIRCUIT' ALARM OCCURRED. THE RESPIRATORY RATE SHOWN WAS HIGHER (40BMP) THAN THE SET VALUE (10BPM). THE PATIENT HAD A COUGHING FIT AND RESPIRATORY DISTRESS; HE WAS THEN MANUALLY VENTILATED WHILE BEING SWITCHED TO ANOTHER VENTILATOR. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. LATER, THE DISTRIBUTOR IDENTIFIED THAT THE CONTROL BOARD WAS FAULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |