CONTROLLER, VEST 105 P105CM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-21 for CONTROLLER, VEST 105 P105CM manufactured by Hill-rom Singapore.

Event Text Entries

[83167184] The patient tripped on the vest and tubing while using her walker and fell. The patient was taken to the hospital via ambulance where it was discovered that she broke some ribs. The patient is unable to use the vest device at this time. The account made no allegation of the vest malfunctioning. Based on this information, no further action is required. This is a serious injury per fda definition.
Patient Sequence No: 1, Text Type: N, H10


[83167185] Hill-rom received a report from the account stating the patient tripped over the vest hoses and broke some ribs. The device was located at the account. There was patient/user injury reported. This report was filed in our complaint handling system as (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008145987-2017-00001
MDR Report Key6808197
Report SourceCONSUMER
Date Received2017-08-21
Date of Report2017-08-10
Date of Event2017-06-28
Date Mfgr Received2017-08-10
Device Manufacturer Date2017-01-25
Date Added to Maude2017-08-21
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 FDA3
Event Location3
Manufacturer ContactERIN PADGETT
Manufacturer Street1069 STATE ROUTE 46 EAST
Manufacturer CityBATESVILLE IN 47006
Manufacturer CountryUS
Manufacturer Postal47006
Manufacturer Phone8129312791
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONTROLLER, VEST 105
Generic NameTHE VEST
Product CodeBYI
Date Received2017-08-21
Model NumberP105CM
OperatorOTHER CAREGIVERS
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM SINGAPORE
Manufacturer Address1 YISHUN AVENUE 7 SINGAPORE, NORTH EAST 768923 SN 768923


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-08-21

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