MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1999-09-10 for LIFESIGNS RECEIVING CENTER 2000 5112-24 manufactured by Alaris Medical Systems Inc..
[19496065]
It was alleged that while on a pt, the nurse experienced difficulty in monitoring the pt's heart rate with the receiver. It was noted that the pt was defibrilllated after cardiac arrest. It was reported that the pt is in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018546-1999-00001 |
| MDR Report Key | 239876 |
| Report Source | 05,07 |
| Date Received | 1999-09-10 |
| Date of Event | 1999-08-04 |
| Date Facility Aware | 1999-08-04 |
| Date Mfgr Received | 1999-08-12 |
| Device Manufacturer Date | 1996-06-01 |
| Date Added to Maude | 1999-09-16 |
| 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 | 3 |
| Manufacturer Contact | SHEINIE WARHAFT |
| Manufacturer Street | 10221 WATERIDGE CR |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584587912 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESIGNS RECEIVING CENTER 2000 |
| Generic Name | RECEIVER |
| Product Code | DXH |
| Date Received | 1999-09-10 |
| Model Number | 5112-24 |
| Catalog Number | 5112-24 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 232430 |
| Manufacturer | ALARIS MEDICAL SYSTEMS INC. |
| Manufacturer Address | 10221 WATERIDGE CIRCLE SAN DIEGO CA 92121 US |
| Baseline Brand Name | LIFESIGNS RECEIVING CENTER 2000 |
| Baseline Generic Name | RECEIVER |
| Baseline Model No | 5112-24 |
| Baseline Catalog No | 5112-24 |
| Baseline ID | NA |
| Baseline Device Family | RECEIVER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951096 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 1999-09-10 |