TREATMENT RECLINER 3500000710

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-25 for TREATMENT RECLINER 3500000710 manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[134190702] This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program. 1 device was evaluated in the field and the issue was confirmed; there was a disconnected component. The device was repaired and returned. 1 device was not evaluated, as the issue was identified and resolved during a troubleshooting call between the customer and stryker technical support. There was no remedial action taken. This device is not labeled for single use.
Patient Sequence No: 1, Text Type: N, H10


[134190703] This report summarizes 2 malfunction event,s where it was reported the backrest became disconnected from the unit. There was patient involvement, however there were no consequences or impacts to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2019-00026
MDR Report Key8279087
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-01-25
Date of Report2019-01-25
Date of Event2018-10-01
Date Mfgr Received2019-01-01
Date Added to Maude2019-01-25
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 ContactMR. MARY KLAVER
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal49002
Manufacturer Phone2693292100
Manufacturer G1STRYKER MEDICAL-KALAMAZOO
Manufacturer Street3800 EAST CENTRE AVENUE
Manufacturer CityPORTAGE MI 49002
Manufacturer CountryUS
Manufacturer Postal Code49002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTREATMENT RECLINER
Generic NameCHAIR, EXAMINATION AND TREATMENT
Product CodeFRK
Date Received2019-01-25
Catalog Number3500000710
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-25

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