FDA Adverse Event
Malfunction
Summary report: N
NIGHTINGALE
MDR report key: 17522799
·
Received August 12, 2023
Report
- Report Number
- MW5129747
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- January 24, 2011
- Manufacturer
- ZOE MEDICAL, INC.
- Product Code
- MWI
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
ON (B)(6) 2010, STRYKER MEDICAL WAS NOTIFIED OF A POTENTIALLY REPORTABLE COMPLAINT INVOLVING A PRODUCT FOR WHICH STRYKER IS NOT THE MANUFACTURER. THE CUSTOMER REPORTED A NIGHTINGALE REMOTE NURSE CALL SYSTEM WAS NOT FUNCTIONING. PLEASE FIND ADDITIONAL CONTACT INFORMATION BELOW. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2244489 | NIGHTINGALE | MONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | MWI | ZOE MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |