MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-07-23 for AMI HEART RATE RESPIRATION MONITOR 9700B manufactured by Cas Medical Systems, Inc..
[16722014]
Home care dealer reported parents comments that their baby started screaming and when parents intervened, a parent got shocked. Numerous attempts at obtaining more detail were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[16908394]
Owner of monitor being uncooperative in this investigation after numerous attempts at obtaining info. Owner dealer is using another biomedical group for the monitor's eval with instructions that cas not be forwarded a copy of the monitor's download. They will do their own benchtesting. No rma requested for the monitor's return.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2244861-2007-00005 |
| MDR Report Key | 884419 |
| Report Source | 08 |
| Date Received | 2007-07-23 |
| Date of Report | 2007-07-23 |
| Date of Event | 2007-06-01 |
| Date Mfgr Received | 2007-06-21 |
| Device Manufacturer Date | 2005-05-01 |
| Date Added to Maude | 2007-08-21 |
| 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 | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMI HEART RATE RESPIRATION MONITOR |
| Generic Name | BREATHING FREQUENCY MONITOR |
| Product Code | BZQ |
| Date Received | 2007-07-23 |
| Model Number | 9700B |
| Lot Number | NA |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 873363 |
| Manufacturer | CAS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 44 EAST INDUSTRIAL RD. BRANFORD CT 06405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-07-23 |