FDA Adverse Event
Injury
Summary report: N
HT50-H1 VENTILATOR
MDR report key: 4221621
·
Received November 3, 2014
Report
- Report Number
- 2023050-2014-00457
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- September 30, 2014
- Report Date
- October 28, 2014
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K082724
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SHIELDED FLAT CABLE ASSEMBLY WAS RETURNED FOR ANALYSIS, AND IT WAS PLACED INTO A TEST VENTILATOR TO VERIFY THE MALFUNCTION. THE CABLE WAS LEFT IN THE TEST UNIT TO PERFORM A BURN TEST, AND NO ERRORS WERE FOUND. IT WAS REMOVED AND INSPECTED FOR DAMAGES, AND NO ANOMALIES WERE FOUND. THE CUSTOMER REPORTED MALFUNCTION WAS NOT VERIFIED.
Additional Manufacturer Narrative · 1
COVIDIEN REFERENCE: (B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION STATING THAT, DURING PATIENT USE OF THE HT50 VENTILATOR, THE DEVICE HAD BEEN ON STANDBY MODE AND STOPPED VENTILATION. NO SHUTDOWN ALARM WAS CONFIRMED. A NURSE NOTICED AND REBOOTED THE DEVICE. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR DUE TO THIS MALFUNCTION. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702844 | HT50-H1 VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |