FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 4211956
·
Received October 29, 2014
Report
- Report Number
- 8020893-2014-02419
- Event Type
- Injury
- Date Received
- October 29, 2014
- Date of Event
- October 11, 2014
- Report Date
- October 15, 2014
- Manufacturer
- COVIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).THE COVIDIEN CUSTOMER SUPPORT ENGINEER INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPLACED THE BREATH DELIVERY (BD) PRINTED CIRCUIT BOARD (PCB) TO RESOLVE THE REPORTED ISSUE.
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION STATING THAT AN 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON A SECOND VENTILATOR. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693585 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |