FDA Adverse Event
Death
Summary report: N
HEART RATE RESPIRATION MONITOR
MDR report key: 865993
·
Received June 15, 2007
Report
- Report Number
- 2244861-2007-00004
- Event Type
- Death
- Date Received
- June 15, 2007
- Date of Event
- April 11, 2004
- Report Date
- June 14, 2007
- Manufacturer
- CAS MEDICAL SYSTEMS, INC.
- Product Code
- FLS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THIS MONITOR WAS NAMED IN A PT LAWSUIT THAT CAS LEARNED OF IN 2006. THE ACTUAL MONITOR NEVER RETURNED TO CAS.
Description of Event or Problem · 1
PARENTS CLAIM MONITOR DID NOT ALARM WHEN MOTHER AWOKE AND FOUND HER CHILD NOT BREATHING. EMS WAS CALLED AND ATTEMPTED RESUSCITATION WITHOUT SUCCESS. CAUSE OF DEATH WAS SAID TO BE SIDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEART RATE RESPIRATION MONITOR | BREATHING FREQUENCY MONITOR | FLS | CAS MEDICAL SYSTEMS, INC. | 9700A | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death |