DPM CENTRAL STATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-01-29 for DPM CENTRAL STATION manufactured by Mindray Ds Usa, Inc..

Event Text Entries

[3172276] The customer reported a loss of communication between the ambulatory telepack and dpm central station. No pt injury was reported.
Patient Sequence No: 1, Text Type: D, B5


[10508756] The company rep evaluated the system and verified the reported problem. The customer was provided with a replacement ambulatory telepack. The system was tested to factory's specifications. It functioned normally and was returned to use.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2221819-2013-00020
MDR Report Key2981007
Report Source06,07
Date Received2013-01-29
Date of Report2013-01-30
Date of Event2012-09-11
Date Added to Maude2013-04-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactWISARA SETHACHUTKUL
Manufacturer Street800 MACARTHUR BLVD.
Manufacturer CityMAHWAH NJ 07430
Manufacturer CountryUS
Manufacturer Postal07430
Manufacturer Phone2019958045
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDPM CENTRAL STATION
Generic NameNONE
Product CodeEIH
Date Received2013-01-29
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMINDRAY DS USA, INC.
Manufacturer AddressMAHWAH NJ US


Patients

Patient NumberTreatmentOutcomeDate
10 2013-01-29

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