MALIBU AJR7112-GB

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 2018-02-23 for MALIBU AJR7112-GB manufactured by Arjo Hospital Equipment Ab.

Event Text Entries

[101142967] (b)(4). Additional information will be provided upon investigation conclusion.
Patient Sequence No: 1, Text Type: N, H10


[101142968] On 2018-jan-24 arjohuntleigh was notified by customer facility about event with involvement of malibu bathtub (serial number: (b)(4)), which occurred on (b)(6) 2018. The caregivers were transferring a patient with the bath chair when they noticed that the chair was sitting at an angle. They moved the patient safely and discovered that the chair safety clip appeared to be reversed. The involved patient did not sustain injuries. When on 2018-jan-25 the arjohuntleig representative attended customer facility, no issues were found. The customer facility representative confirmed that they had refitted the safety clips on bath.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007420694-2018-00046
MDR Report Key7293075
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2018-02-23
Date of Report2018-04-13
Date of Event2018-01-12
Date Facility Aware2018-01-24
Report Date2018-04-13
Date Reported to FDA2018-04-13
Date Reported to Mfgr2018-04-13
Date Mfgr Received2018-02-24
Device Manufacturer Date2003-11-10
Date Added to Maude2018-02-23
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 ContactMS. KINGA STOLINSKA
Manufacturer StreetKS. WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI, 62-052
Manufacturer CountryPL
Manufacturer Postal62-052
Manufacturer G1ARJO HOSPITAL EQUIPMENT AB
Manufacturer StreetVERKSTADSVAGEN 5
Manufacturer CityESLOV, 24121
Manufacturer CountrySW
Manufacturer Postal Code24121
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMALIBU
Generic NameBATH, HYDRO-MASSAGE
Product CodeILJ
Date Received2018-02-23
Model NumberAJR7112-GB
OperatorOTHER CAREGIVERS
Device AvailabilityY
Device Age14 YR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARJO HOSPITAL EQUIPMENT AB
Manufacturer AddressVERKSTADSVAGEN 5 ESLOV, 24121 SW 24121


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-02-23

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