DATASCOPE 3000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-11 for DATASCOPE 3000 manufactured by Datascope Corporation.

Event Text Entries

[969] Consecutive blood pressure readings were identical at 129/73. Manual check of blood pressure obtained and was 54/30. Patient required administration of ephedrine and intravenous fluids to restore blood pressure to accestable level. Malfunction could not be duplicated by hospital bio-medical technician upon evaluation after event. Unit returned to manufacturer to evaluate and service if necessarydevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-feb-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, performance tests performed. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3921
• MDR Report Key: 3921
• Date Received: 1993-02-11
• Date of Report: 1992-09-15
• Date of Event: 1992-09-11
• Date Facility Aware: 1992-09-11
• Report Date: 1992-09-15
• Date Reported to Mfgr: 1992-09-15
• Date Added to Maude: 1993-05-07
• 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
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DATASCOPE
• Generic Name: VITAL SIGN MONITOR
• Product Code: KRK
• Date Received: 1993-02-11
• Model Number: 3000
• ID Number: 13-03905
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-APR-90
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3661
• Manufacturer: DATASCOPE CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-02-11