FDA Adverse Event
Malfunction
Summary report: N
HEART RATE RESPIRATION MONITOR
MDR report key: 1150094
·
Received August 29, 2008
Report
- Report Number
- 2244861-2008-00001
- Event Type
- Malfunction
- Date Received
- August 29, 2008
- Date of Event
- June 1, 2008
- Report Date
- August 28, 2008
- Manufacturer
- CAS MEDICAL SYSTEMS, INC.
- Product Code
- FLS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RESULTS - BATTERY DID HAVE ABOUT A 2 HOUR CHARGE ON THE BATTERY. IT WAS NOT DEAD WHEN RECEIVED. CAS TESTING WAS TO RUN THE BATTERY DOWN TO THE POINT OF ALARMING FOR A LOW BATTERY, WHICH IT DID AS SPECIFIED. CONCLUSIONS - THE HOSPITAL REFUSES TO SHARE THE "INCIDENT REPORT" SO IT CANNOT BE DETERMINED IF THE LOW BATTERY NOT ALARMING WAS THE "INCIDENT" OR SOMETHING ELSE CONTRIBUTED TO AN INCIDENT.
Description of Event or Problem · 1
AS DESCRIBED BY A REPRESENTATIVE OF THE HOSPITAL, THE MONITOR REPORTEDLY HAD A DEAD BATTERY AND NO ALARM WAS HEARD. THE REPORTER FILED AN INTERNAL INCIDENT REPORT, AND THE HOSPITAL SPOKESPERSON IS TRYING TO OBTAIN AND PROVIDE THAT REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART RATE RESPIRATION MONITOR | BREATHING FREQUENCY MONITOR | FLS | CAS MEDICAL SYSTEMS, INC. | 511 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |