SUPPORT ARM 177 6481720

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-09-19 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.

Event Text Entries

[4921795] It was reported that the support arm broke. There was no pt involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[12406962] No aprts are available for investigation since they were scrapped by the customer. Due to this fact, the root cause of the breakage cannot be established. According to the received info the support arm broke at the joint nearest to the bracket. No info regarding mfg date of the support arm has been received. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number8010042-2014-00429
MDR Report Key4119095
Report Source05,06,07
Date Received2014-09-19
Date of Report2014-08-20
Date Facility Aware2014-08-20
Report Date2014-09-19
Date Reported to Mfgr2014-08-22
Date Mfgr Received2014-08-20
Date Added to Maude2014-10-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJANICE PEVIDE
Manufacturer Street45 BARBOUR POND DR
Manufacturer CityWAYNE NJ 07470
Manufacturer CountryUS
Manufacturer Postal07470
Manufacturer Phone9737097753
Manufacturer G1MAQUET CRITICAL CARE AB
Manufacturer CitySOLNA S-17154
Manufacturer CountrySW
Manufacturer Postal CodeS-17154
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPPORT ARM 177
Product CodeIOY
Date Received2014-09-19
Catalog Number6481720
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CRITICAL CARE AB
Manufacturer AddressSOLNA SW


Patients

Patient NumberTreatmentOutcomeDate
10 2014-09-19

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