FDA Adverse Event
Injury
Summary report: N
HT50 VENTILATOR
MDR report key: 4223348
·
Received November 4, 2014
Report
- Report Number
- 2023050-2014-00453
- Event Type
- Injury
- Date Received
- November 4, 2014
- Date of Event
- September 19, 2014
- Report Date
- October 7, 2014
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS
- Product Code
- CBK
- PMA / PMN Number
- K082724
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER CAREGIVERS
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN REQUESTED BUT NOT RETURNED. (B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE OF THE HT50 VENTILATOR, THE PATIENT'S WIFE NOTICED STRANGE NOISES FROM THE DEVICE. THE DEVICE WAS REPLACED. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707897 | HT50 VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS | HT50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |