SUPPORT ARM 177 6481720

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-03 for SUPPORT ARM 177 6481720 manufactured by Maquet Critical Care Ab.

Event Text Entries

[37781779] (b)(4). Further information regarding the event has been sought. A supplemental medwatch report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


[37781780] It was reported that the support arm for the ventilator broke. There was no patient involvement. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[42408078] No parts were returned. Investigation was based on pictures received. According to the pictures provided by the customer, the support arm broke at the joint nearest to the bracket. Prior investigations of similar breakages showed that the cause for the damage can be attributed to the following: cracks / porosity in the casting process, overload, use outside of its specification. Previously performed investigations have lead to a redesign and a change of the manufacturing process in order to obtain a higher mechanical strength of the support arms. This was implemented in production during may 2009. However, despite the attempts to obtain pictures showing the manufacturing date, no additional information has been received. Therefore, the root cause for the breakage cannot be established from this investigation.
Patient Sequence No: 1, Text Type: N, H10


[42408079] (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8010042-2016-00060
MDR Report Key5408318
Date Received2016-02-03
Date of Report2016-01-04
Date Mfgr Received2016-01-04
Date Added to Maude2016-02-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer StreetMAQUET CRITICAL CARE AB R
Manufacturer CitySOLNA
Manufacturer CountrySW
Manufacturer G1MAGNUS LINDQVIST
Manufacturer StreetMAQUET CRITICAL CARE AB R
Manufacturer CitySOLNA
Manufacturer CountrySW
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPPORT ARM 177
Generic NameSUPPORT, ARM
Product CodeIOY
Date Received2016-02-03
Catalog Number6481720
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CRITICAL CARE AB
Manufacturer AddressSOLNA SW


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-03

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