SANDMAN DIGITAL 20 (SD20) SD20 AMPL/HEADBOX D.2118/D.2120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-05-16 for SANDMAN DIGITAL 20 (SD20) SD20 AMPL/HEADBOX D.2118/D.2120 manufactured by Eb Neuro Spa.

Event Text Entries

[856333] Nellcor puritan bennett received a report from a sleep facility that "a pt complained of shocking feeling that occurred when the customer connected the pt headbox to the headbox cable. Later, that evening the pt complained of a tingling feeling from the iso ground lead", but continued with the study throughout the night. In the morning, the sleep facility further reported that the pt complained of a burn where one of the leads had been connected. The pt was referred to and treated by a dermatologist who prescribed antibiotic cream.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number9680138-2008-00001
MDR Report Key1051497
Date Received2008-05-16
Date of Report2008-05-16
Date of Event2008-04-16
Date Added to Maude2008-05-28
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSANDMAN DIGITAL 20 (SD20)
Generic Name*
Product CodeGWL
Date Received2008-05-16
Returned To Mfg2008-05-12
Model NumberSD20 AMPL/HEADBOX
Catalog NumberD.2118/D.2120
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key1019852
ManufacturerEB NEURO SPA
Manufacturer AddressVIA PIETRO FANFANI 97/A 97/A FIRENZE (FI) IT 50127

Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-05-16
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