MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2007-08-14 for AMI PLUS MONITOR 9700B 01-05-0170 manufactured by Cas Medical Systems, Inc..
[21473336]
Initial eval. Performed to confirm or refute claim. The alarms functioned properly but were found to be dirty. Replace as part of routing recertification/maintenance. See scanned pages.
Patient Sequence No: 1, Text Type: N, H10
[21590583]
A parent/user reported to the home care dealer that the monitors audio alarm did not function. There was no mention of a problem with the unit not actually monitoring the patient correctly. The home care dealer did not witness the problem and it is not shown on the memory download equipment alarm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2244861-2007-00006 |
| MDR Report Key | 897396 |
| Report Source | 08 |
| Date Received | 2007-08-14 |
| Date of Report | 2007-08-14 |
| Date of Event | 2007-07-01 |
| Date Mfgr Received | 2007-07-16 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2007-09-28 |
| 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 PLUS MONITOR |
| Generic Name | BREATHING FREQUENCY MONITOR |
| Product Code | BZQ |
| Date Received | 2007-08-14 |
| Returned To Mfg | 2007-07-20 |
| Model Number | 9700B |
| Catalog Number | 01-05-0170 |
| Lot Number | NA |
| ID Number | RGA7047 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 876729 |
| Manufacturer | CAS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 44 E. INDUSTRIAL RD. BRANFORD CT 06405 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-14 |