ZOOM STRETCHER, PRIME X 1125 1125000000X

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 2020-01-31 for ZOOM STRETCHER, PRIME X 1125 1125000000X manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[177423800] The customer reported that a porter using electric trolley on (b)(6) when power failed (zoom disengaged during use) and the porter took all the weight of trolley and patient. Another porter assisted in the safe transfer of the patient. The incident caused porter a 2-3 month absence due to back pain. The porter has now returned to work on light duties and continues to receive physiotherapy.
Patient Sequence No: 1, Text Type: D, B5


[182486092] The awareness date has been updated to reflect the date stryker became aware of the incident.
Patient Sequence No: 1, Text Type: N, H10


[182486093] The customer reported that a porter using electric trolley on north street when power failed (zoom disengaged during use) and the porter took all the weight of trolley and patient. Another porter assisted in the safe transfer of the patient. The incident caused porter a 2-3 month absence due to back pain. The porter has now returned to work on light duties and continues to receive physiotherapy.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0001831750-2020-00298
MDR Report Key9655671
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-31
Date of Report2020-02-04
Date of Event2018-11-17
Date Mfgr Received2020-01-27
Date Added to Maude2020-01-31
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. KRISTEN CANTER
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 NameZOOM STRETCHER, PRIME X
Generic NameSTRETCHER, WHEELED, POWERED
Product CodeINK
Date Received2020-01-31
Model Number1125
Catalog Number1125000000X
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER MEDICAL-KALAMAZOO
Manufacturer Address3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-01-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.