MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-02 for DATASCOPE 052390 UNK manufactured by Datascope Corp..
[17441173]
A telemetry monitor was attached to a patient without notifying the monitor tech. The tech noted they were not receiving an image when they were told patient there was a patient in the room 5 1/2 hours latter. A new battery was placed in the monitor and the patient was noted to be in normal sinus rhythm without incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 611115 |
| MDR Report Key | 611115 |
| Date Received | 2005-06-02 |
| Date of Report | 2005-05-16 |
| Date of Event | 2005-04-01 |
| Report Date | 2005-05-16 |
| Date Reported to FDA | 2005-06-02 |
| Date Added to Maude | 2005-06-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DATASCOPE |
| Generic Name | TELEMETRY MONITOR |
| Product Code | GYE |
| Date Received | 2005-06-02 |
| Model Number | 052390 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Implant Flag | * |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 600909 |
| Manufacturer | DATASCOPE CORP. |
| Manufacturer Address | 800 MACARTHUR BLVD. MAHWAH NJ 07430 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-02 |