VEST MODEL 105 8105 P105CM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-04-05 for VEST MODEL 105 8105 P105CM manufactured by Hillrom Services Private Limited.

Event Text Entries

[19733193] Hill-rom received a complaint on one of its vest model 105 airway clearance devices alleging the patient's rib was fractured after treatment. The report indicated that the patient had used the device slightly longer than what was recommended by her trainer. No malfunction of the device was alleged nor found through the analysis of the unit.
Patient Sequence No: 1, Text Type: D, B5


[19834275] No malfunction of the device was alleged nor found through the analysis of the unit.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3008145987-2013-00001
MDR Report Key3054690
Report Source00
Date Received2013-04-05
Date of Report2013-03-27
Date of Event2013-03-27
Date Facility Aware2013-03-27
Report Date2013-03-27
Date Reported to FDA2013-04-05
Date Mfgr Received2013-03-27
Device Manufacturer Date2012-12-19
Date Added to Maude2013-04-15
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 ContactROBERT FARLEY
Manufacturer Street4349 CORPORATE ROAD
Manufacturer CityCHARLESTON SC 29405
Manufacturer CountryUS
Manufacturer Postal29405
Manufacturer Phone8437408506
Manufacturer G1HILL-ROM SERVICES PRIVATE LIMITED
Manufacturer Street1 YISHUN AVENUE 7
Manufacturer CitySINGAPORE 768923
Manufacturer CountrySN
Manufacturer Postal Code768923
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameVEST MODEL 105
Generic NamePERCUSSOR, POWERED-ELECTRIC
Product CodeBYI
Date Received2013-04-05
Returned To Mfg2013-03-27
Model Number8105
Catalog NumberP105CM
Device Expiration Date2012-12-19
OperatorLAY USER/PATIENT
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHILLROM SERVICES PRIVATE LIMITED
Manufacturer Address1 YISHUN AVENUE 7 SINGAPORE 768923 SN 768923


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-04-05

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