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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GARDEN CITY MEDICAL TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL

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GARDEN CITY MEDICAL TRANSPORT 20 IN X 16 IN 9153637574; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number 9105
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Dealer states that when the caregiver stepped on the step tube it broke off.
 
Manufacturer Narrative
A returned was issued and the product is awaiting receipt and/or evaluation.A follow up will be filed if/when any additional information is provided.
 
Manufacturer Narrative
A returned was issued and the product was evaluated upon receipt.The following field have been updated.
 
Event Description
Dealer states that when the caregiver stepped on the step tube it broke off.
 
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Brand Name
TRANSPORT 20 IN X 16 IN 9153637574
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
GARDEN CITY MEDICAL
15 s. main st.
pmi - probasics - pinnacle
marlboro NJ 07746
Manufacturer (Section G)
GARDEN CITY MEDICAL
15 s. main st.
pmi - probasics - pinnacle
marlboro NJ 07746
Manufacturer Contact
kevin guyton
one invacare way
elyria, OH 44035
8003336900
MDR Report Key4881797
MDR Text Key6263896
Report Number1125779-2015-00135
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor,distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 07/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number9105
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/05/2015
Initial Date FDA Received07/01/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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