FDA Adverse Event
Injury
Summary report: N
HT50 VENTILATOR
MDR report key: 4181079
·
Received October 17, 2014
Report
- Report Number
- 2023050-2014-00437
- Event Type
- Injury
- Date Received
- October 17, 2014
- Date of Event
- September 16, 2014
- Report Date
- September 17, 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
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Additional Manufacturer Narrative · 1
(B)(4). IT WAS REPORTED BY THE CUSTOMER THAT THE PUMP WAS REPLACED TO RESOLVE THE REPORTED ISSUE.
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMTION STATING THAT DURING PATIENT USE, AN ABNORMAL NOISE WAS DETECTED FROM THE PUMP OF THE HT50 VENTILATOR. ALTHOUGH THE VENTILATOR DID NOT STOP CYCLING, THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661319 | HT50 VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |