DATASCOPE 9121 3678-K-7

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-08 for DATASCOPE 9121 3678-K-7 manufactured by Datascope Corporation.

Event Text Entries

[1359] Patient was in nursery a 8/26/92 after delivery. At 0125 a ecclymatic area was noted on right great toe. The 0-2 sensor was placed on toe after birth and was in place for approx. 2-hours 40 minutes. After discovery on area sensor was moved to another toe then the left foot. The sensor was moved frequently after injury was noted. Right great toe assessment:eccohymosis with skin harchness and echema. Toe was treated by physician. Pulse ox was taken out of service by respiratory therapy. Bio med checked pulsew ox and probe without any negative findings. Unit sent to manufacturer per their requestdevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-jun-92. Service provided by: distributor. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2061
• MDR Report Key: 2061
• Date Received: 1993-01-08
• Date of Report: 1992-11-25
• Date of Event: 1992-08-26
• Date Facility Aware: 1992-08-26
• Report Date: 1992-11-25
• Date Reported to FDA: 1992-11-25
• Date Reported to Mfgr: 1992-08-31
• Date Added to Maude: 1993-01-12
• 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: PULSE OXIMETER
• Product Code: KLK
• Date Received: 1993-01-08
• Model Number: 9121
• Catalog Number: 3678-K-7
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 1932
• Manufacturer: DATASCOPE CORPORATION

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-01-08