FDA Adverse Event Injury Summary report: N

DATASCOPE

MDR report key: 2061 · Received January 8, 1993

Report

Report Number: 2061
Event Type: Injury
Date Received: January 8, 1993
Date of Event: August 26, 1992
Report Date: November 25, 1992
Manufacturer: DATASCOPE CORPORATION
Product Code: KLK
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DATASCOPE	PULSE OXIMETER	KLK	DATASCOPE CORPORATION	9121

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention