FDA Adverse Event
Injury
Summary report: N
HT50 VENTILATOR
MDR report key: 3940663
·
Received June 25, 2014
Report
- Report Number
- 2023050-2014-00264
- Event Type
- Injury
- Date Received
- June 25, 2014
- Date of Event
- May 27, 2014
- Report Date
- May 28, 2014
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K992133
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EVAL / REPAIR OF THIS UNIT HAVE NOT YET BEGUN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT, DURING PT USE, THE HT50 VENTILATOR GENERATED AN UNK UNSTOPPABLE ALARM. THE MANOMETER WAS OBSERVED TO BE SCALING OUT. THE LIGHT EMITTING DIODES (LED), DID NOT LIT WHEN THE ALARM OCCURRED. THE AIR DELIVERY WAS TOO WEAK (PEEP SETTING WAS AT 3CMH20). THE PANEL BUTTONS BECAME INOPERATIVE. THE PT WAS MANUALLY VENTILATED, AND TRANSFERRED TO ANOTHER UNIT. THERE WAS NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 369656 | HT50 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |