MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 1998-01-22 for MODEL 500 INFANT MONITOR 0500CEH manufactured by Corometrics Medical Sys. Inc..
[92581]
The account rec'd a report from the caregiver of no audio alarm. The account confirmed this report and returned the unit to the mfr for repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216774-1998-00001 |
| MDR Report Key | 145879 |
| Report Source | 01 |
| Date Received | 1998-01-22 |
| Date of Report | 1997-12-18 |
| Date Mfgr Received | 1997-12-18 |
| Device Manufacturer Date | 1997-02-01 |
| Date Added to Maude | 1998-01-28 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MODEL 500 INFANT MONITOR |
| Generic Name | ECG/RESPIRATION MONITOR |
| Product Code | KXN |
| Date Received | 1998-01-22 |
| Returned To Mfg | 1998-01-07 |
| Model Number | 500 INFANT MONITOR |
| Catalog Number | 0500CEH |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 142199 |
| Manufacturer | COROMETRICS MEDICAL SYS. INC. |
| Manufacturer Address | 61 BARNES PARK RD. NORTH WALLINGFORD CT 064920333 US |
| Baseline Brand Name | MODEL 500 INFANT MONITOR |
| Baseline Generic Name | ECG/RESPIRATION MONITOR |
| Baseline Model No | 500 INFANT MONI |
| Baseline Catalog No | 0500CEH |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-01-22 |