DATASCOPE UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-10 for DATASCOPE UNK manufactured by Datascope Corporation.

Event Text Entries

[17018944] The datascope telemetry monitors were switched on patients in room for 14 hours. The error was discovered when one of the patients was discharged. The monitor strip showed flutter for a patient in normal sinus and vice versa. The patient with flutter did not receive any treatment. The cardiologist was made aware monitors were switched on patients and the correct readings were provided. There was no harm noted to patient.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 617280
• MDR Report Key: 617280
• Date Received: 2005-06-10
• Date of Report: 2005-06-07
• Date of Event: 2005-05-19
• Report Date: 2005-06-07
• Date Reported to FDA: 2005-06-10
• Date Added to Maude: 2005-06-28
• 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

Device Sequence Number: 1

• Brand Name: DATASCOPE
• Generic Name: CARDIAC TELEMETRY
• Product Code: GYE
• Date Received: 2005-06-10
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: NURSE
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 606982
• Manufacturer: DATASCOPE CORPORATION
• Manufacturer Address: PATIENT MONITORING DIVISION 800 MACARTHUR BOULEVARD MAHWAH NJ 07430 US

Device Sequence Number: 2

• Brand Name: DATASCOPE
• Generic Name: TELEMETRY MONITOR
• Product Code: GYE
• Date Received: 2005-06-10
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 606983
• Manufacturer: DATASCOPE CORPORATION
• Manufacturer Address: PATIENT MONITORING DIVISION 800 MACARTHUR BOULEVARD MAHWAH NJ 07430 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-06-10
2	0		2005-06-10