ADVANTA 2 FRAME P1190A000091

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-11 for ADVANTA 2 FRAME P1190A000091 manufactured by Hill-rom Mexico.

Event Text Entries

[186870699] The hillrom technician found the four brake casters needed to be replaced. Per the hillrom service manual the bed should be subject to an effective maintenance program. An annual service of the bed is advised in order to maintain its characteristics and performance. Brake casters should be checked for cuts, wear and quality of tread, etc. And replaced when necessary. Check the brakes to see whether the bed moves when the brake bar or the lh/rh brake pedals are pressed. Repair as necessary. A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in november 2019. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the four brake casters to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[186870700] Hillrom received a report from a hillrom technician stating the bed's brakes were not holding. The bed was located in the bed shop at the account. There was no patient/user injury reported. This report was filed in our complaint handling system as complaint # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006697241-2020-00019
MDR Report Key9821884
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-11
Date of Report2020-03-02
Date of Event2020-03-02
Date Mfgr Received2020-03-02
Device Manufacturer Date2011-10-19
Date Added to Maude2020-03-11
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 ContactLORI DAULTON
Manufacturer Street1069 STATE ROUTE 46 EAST
Manufacturer CityBATESVILLE IN 47006
Manufacturer CountryUS
Manufacturer Postal47006
Manufacturer Phone8129312280
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameADVANTA 2 FRAME
Generic NameBED, AC-POWERED ADJUSTABLE HOSPITAL
Product CodeFNL
Date Received2020-03-11
Model NumberP1190A000091
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHILL-ROM MEXICO
Manufacturer AddressAVE.DEL TELEFONO NO. 200 COL. HUINALA APODACA, NUEVO LEON 66640 MX 66640


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-11

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