ADVANTA 2 FRAME P1190A000067

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 P1190A000067 manufactured by Hill-rom Mexico.

Event Text Entries

[186870186] The hillrom technician found the side communication cable needed to be replaced. Per the hillrom service manual the advanta? 2 should be subject to an effective maintenance program. This will help make sure of a long, operative life for the advanta? 2 bed. The preventative maintenance will help to reduce downtime due to excessive wear failures. An annual service of the bed is advised in order to maintain its characteristics and performance. Sidecom communication system: inspect and test the communication junction box. Make sure the sidecom? Communication system features operate correctly. Inspect the communication cable, including the male and female pins in the plug. Replace as necessary. A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in february 2019. It is unknown if the facility performed any other preventative maintenance on this bed. The technician replaced the side communication cable to resolve the issue. Based on this information, no further action is required.
Patient Sequence No: 1, Text Type: N, H10


[186870187] Hillrom received a report from a hillrom technician stating the bed was not sending a bed exit alarm to the nurses' station. The bed was located in room (b)(6) 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 Number3006697241-2020-00016
MDR Report Key9820959
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-11
Date of Report2020-02-13
Date of Event2020-02-13
Date Mfgr Received2020-02-13
Device Manufacturer Date2014-12-17
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 NumberP1190A000067
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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