MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-05-09 for HEART RATE MONITOR 9700B NA manufactured by Cas Medical Systems, Inc..
[20928624]
Home care dealer reports a 20 minutes gap in the monitors trace printout. In a comment somewhat off-hand, it was stated that the reason for the inquiry was because a pt had died. The person reporting this said the monitor was not implicated.
Patient Sequence No: 1, Text Type: D, B5
[21066045]
Monitor not returned. Repeated calls to reporter does not produce new info. There is legal involvement tying up the monitors return and they are reluctant to discuss the "case", except to say that they do not believe the monitor malfunctioned or was in any way implicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2244861-2007-00002 |
| MDR Report Key | 850395 |
| Report Source | 06 |
| Date Received | 2007-05-09 |
| Date of Report | 2007-05-09 |
| Date Mfgr Received | 2007-04-11 |
| Date Added to Maude | 2007-05-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RON JEFFREY |
| Manufacturer Street | 44 EAST INDUSTRIAL RD |
| Manufacturer City | BRANFORD CT 06405 |
| Manufacturer Country | US |
| Manufacturer Postal | 06405 |
| Manufacturer Phone | 2034886056 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEART RATE MONITOR |
| Generic Name | BREATHING FREQUENCY MONITOR |
| Product Code | BZQ |
| Date Received | 2007-05-09 |
| Model Number | 9700B |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 837355 |
| Manufacturer | CAS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | * BRANFORD CT 06405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-09 |