DIGISENSOR (FOR ACCUSAT PULSE OXIMETER) 0998-00-0062-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-09 for DIGISENSOR (FOR ACCUSAT PULSE OXIMETER) 0998-00-0062-02 manufactured by Datascope Corporation.

Event Text Entries

[2367] The sensor was used to monitor sa 02 of a patient during surgery. After almost stopping the procedure, the staff switched sensors and identified the sensor as the cause of the low readings. For testing purposes, the sensor was conected to another sa 02 monitor and caused this monitor to also have low readings. The sensor was tested with the aid, via telephone, of datascope engineers and it passed their performance tests and maet their electrical specification according to their procedure. The sensor passed their tests but does not function correctlydevice not labeled for single use. Patient medical status prior to event: invalid data. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: user facility biomedical/bioengineering department. Service records not 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, electrical tests performed, performance tests performed, visual examination. Results of evaluation: electrical problem, modification of device. Conclusion: device was out of calibration. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2889
• MDR Report Key: 2889
• Date Received: 1992-07-09
• Date of Report: 1992-02-25
• Date of Event: 1991-12-01
• Date Facility Aware: 1991-12-01
• Report Date: 1992-02-25
• Date Reported to Mfgr: 1991-12-02
• Date Added to Maude: 1993-04-01
• 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: DIGISENSOR (FOR ACCUSAT PULSE OXIMETER)
• Generic Name: SA 02 SENSOR
• Product Code: LWO
• Date Received: 1992-07-09
• Model Number: DIGISENSOR
• Catalog Number: 0998-00-0062-02
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2707
• Manufacturer: DATASCOPE CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-09