FDA Adverse Event
Malfunction
Summary report: N
REMOTE ALARM
MDR report key: 3000936
·
Received February 27, 2013
Report
- Report Number
- 2518422-2013-00307
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 6, 2013
- Report Date
- February 6, 2013
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K862212
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4): WAITING FOR APPROVAL OF ESTIMATE.
Description of Event or Problem · 1
A REMOTE ALARM WAS RETURNED TO THE MANUFACTURER FOR PREVENTATIVE MAINTENANCE. THE DEVICE WAS NOT IN PT USE. THE REMOTE ALARM WAS EVALUATED BY THE MANUFACTURER. THE COMPLAINT WAS CONFIRMED. THE MANUFACTURER FOUND THE DEVICE'S AUDIBLE ALARM WAS NOT FUNCTIONING. THE PCB WAS REPLACED TO CORRECT THE PROBLEM. IF THE REMOTE ALARM (OPTIONAL ACCESSORY) WAS USED IN CONJUNCTION WITH A VENTILATOR, THE VENTILATOR WOULD CONTINUE TO PROVIDE THERAPY AND AUDIBLY ALARM FOR PT EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83923 | REMOTE ALARM | VENTILATORY CONTINUOUS FACILITY USE | CBK | RESPIRONICS, INC. | 34003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |