MAUDE Adverse Event Report: PRISM MEDICAL TRANSITION GATE BRACKET MOUNT FOR REG. TRACK

Model Number 363980

Device Problems Component Falling (1105); Device Dislodged or Dislocated (2923); Fail-Safe Problem (2936); Installation-Related Problem (2965)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

The transition gate parts have been requested back to evaluate.An investigation will be completed and a final report submitted after completion of investigation.

Event Description

Motor fell out of track when health care worker pushed it away after use.No one was injured.

Manufacturer Narrative

Root cause: primary: indications of poor bracket positioning, increased deflection of the system, and excess wear on the brackets suggest that the installation is the primary cause.These issues prevented the guide screw from completely engaging with the ramp.Secondary: as the pin did not slide easily through the plastic linear bearings, the pin did not drop down as designed.Remaining in the "up" position, it allowed the lift to roll out of the track.Correction: check the installation to ensure it is level and does not have large gaps between the track.The transgate components returned should be replaced.Corrective action: primary: the installation of the remaining systems installed at the facility should be checked to ensure they are level and do not have large gaps between the track.The installation crew and facility staff should be retrained to confirm clear understanding of proper install/use of the gantry system.Secondary: the plastic bearing for the transgate was upgraded in mid-2015 (ecr 802) and current production utilizes a different metal roller bearing instead.The replaced transgate components will have metal roller bearings installed which should allow the drop pin to move more freely.

• Brand Name: TRANSITION GATE BRACKET MOUNT FOR REG. TRACK
• Type of Device: TRANSITION GATE
• Manufacturer (Section D): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer (Section G): PRISM MEDICAL; 10888 metro court; maryland heights MO 63043
• Manufacturer Contact: steve kilburn ; 10888 metro court; maryland heights, MO 63043 ; 3142198614
• MDR Report Key: 5518223
• MDR Text Key: 41174327
• Report Number: 3007802293-2016-00053
• Device Sequence Number: 1
• Product Code: FMR
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 363980
• Is the Reporter a Health Professional?: No
• Device Age: 2 YR
• Event Location: Hospital
• Date Manufacturer Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Weight: 100