MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-04-04 for AMI PLUS MONITOR 9700B 01-05-0170 manufactured by Cas Medical Systems, Inc..
[18801225]
After the monitor was evaluated by the home care dealer it was returned to cas where it was further run for over 1 week all the while challenged with input data designed to cause alarm events. The monitor worked as it should.
Patient Sequence No: 1, Text Type: N, H10
[19105096]
As reported by the home care dealer, the parents entered the baby's room and saw the alarm lights on and subsequently informed the apnea program people that the monitor did not alarm. There was no impact to the baby reported. The monitor was given to the home care company.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2244861-2012-00002 |
| MDR Report Key | 2541857 |
| Report Source | 08 |
| Date Received | 2012-04-04 |
| Date of Report | 2012-04-03 |
| Date of Event | 2012-03-06 |
| Date Mfgr Received | 2012-03-08 |
| Device Manufacturer Date | 2003-02-01 |
| Date Added to Maude | 2012-09-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | APNEA MONITOR |
| Product Code | BZQ |
| Date Received | 2012-04-04 |
| Returned To Mfg | 2012-03-14 |
| Model Number | 9700B |
| Catalog Number | 01-05-0170 |
| ID Number | RMA 20286 PC 4268 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | BRANFORD CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-04 |