MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-03-07 for AMI PLUS MONITOR 9700B manufactured by Cas Medical Systems, Inc..
[21986540]
As reported by the home care dealer, the device, used for apnea monitoring, was alleged to not be alarming when the mother looked in on the baby and observed the baby to have a blue coloration. The mom then startled the baby. It was not stated if the mom's reaction caused a restart of the baby's breathing. No trip to the hosp was necessary. The report states that the monitor had alarmed for apnea two previous times. The distributor reports that the monitors led's indicated that the monitor was counting heart rate and respiration.
Patient Sequence No: 1, Text Type: D, B5
[22198937]
Cas intends to test / run this device over an extended period, which as of today, is just 6 days of testing. The monitor after 2 days is operating and responding correctly. Testing will continue with negative results not expected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2244861-2012-00001 |
| MDR Report Key | 2489370 |
| Report Source | 08 |
| Date Received | 2012-03-07 |
| Date of Report | 2012-03-07 |
| Date of Event | 2012-02-08 |
| Date Mfgr Received | 2012-03-01 |
| Date Added to Maude | 2012-08-28 |
| 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 | 0 |
| Health Professional | 0 |
| 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 | BREATHING FREQUENCY MONITOR, APNEA MONITOR |
| Product Code | BZQ |
| Date Received | 2012-03-07 |
| Returned To Mfg | 2012-03-05 |
| Model Number | 9700B |
| ID Number | RMA 20247 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2012-03-07 |