FDA Adverse Event
Injury
Summary report: N
HT70 VENTILATOR
MDR report key: 3851105
·
Received May 22, 2014
Report
- Report Number
- 2023050-2014-00211
- Event Type
- Injury
- Date Received
- May 22, 2014
- Date of Event
- February 22, 2014
- Report Date
- April 23, 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 RETURNED COMPONENT HAS BEEN RECEIVED BY THE MFR SERVICE CENTER FOR FURTHER FAILURE ANALYSIS. AS ADDITIONAL INFO IS OBTAINED A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem · 1
A REPORT RECEIVED FROM (B)(6) STATED AN HT70 VENTILATOR EXPERIENCED A BACKUP BATTERY FAILURE WHILE CONNECTED TO THE ALTERING CURRENT (A/C). THERE WAS A PT CONNECTED TO THE VENTILATOR AT THE TIME OF THE INCIDENT. THE PT WAS REMOVED FROM THE DEVICE, AMBU BAGGED, AND SWITCHED TO AN ALTERNATE VENTILATOR. THERE WAS NO REPORT OF PT INJURY AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 306658 | HT70 VENTILATOR | CBK. NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |