FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 3911590
·
Received May 27, 2014
Report
- Report Number
- 2023050-2014-00219
- Event Type
- Injury
- Date Received
- May 27, 2014
- Date of Event
- April 25, 2014
- Report Date
- April 28, 2014
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DISTRIBUTOR INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE DISTRIBUTOR REPORTED TO HAVE REPLACED THE MEMBRANE AND OVERLAY TO RESOLVE THE ISSUE. (B)(4).
Description of Event or Problem · 1
A REPORT RECEIVED FROM (B)(6) STATED AN HT70 VENTILATOR EXPERIENCED AN UNRESPONSIVE ALARM WITH A RANDOMLY BLINKING SILENCE /RESET LIGHT EMITTING DIODE (LED). THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. THE PATIENT WAS REMOVED FORM THE DEVICE, AMBU BAGGED THEN SWITCHED TO AN ALTERNATE VENTILATOR. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311432 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |