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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TOLLOS PATIENT TRANSFER AID ; "LIFT, PATIENT, NON - AC - POWERED"

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TOLLOS PATIENT TRANSFER AID ; "LIFT, PATIENT, NON - AC - POWERED" Back to Search Results
Model Number TUL3510XH
Device Problems Break (1069); Material Disintegration (1177); Component Missing (2306); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981); Naturally Worn (2988)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
During our annual inspection of our tollos lifts (model tul3510xh) in november of 2018, two lifts had severe damage to the spreader bar assembly.The following was found: the thrust bearing washer was in pieces; the spreader bar short pivot bushing was damaged to the point where the top section was missing; the external retaining ring was bent and had become dislodged from the groove in the spreader bar pin; the spreader bar weldment had extreme wear where the spreader bar pin passes through the spreader bar.This was due to the bearing rubbing directly on the softer spreader bar after the thrust bearing washer and the spreader bar short pivot bushing disintegrated; the needle roller bearing was found to have become cupped due to the fact that it started to wear through the spreader bar causing the hole in the spreader bar to become cupped; the area of the spreader bar pin where the bearing rides was noted to be rough and not machined smooth.Four other units were caught early enough where no damage to the spreader bar assembly itself happened.The bad parts were replaced and the units put back into service.They required the following parts: one retaining ring and one short pivot bushing; one retaining ring and one short pivot bushing; one retaining ring, one short pivot bushing, and one trust bearing washer; one retaining ring, one short pivot bushing, and one trust bearing washer.Note: the design lacks needed thrust washer between bearing and pin thrust shoulder.
 
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Brand Name
PATIENT TRANSFER AID
Type of Device
"LIFT, PATIENT, NON - AC - POWERED"
Manufacturer (Section D)
TOLLOS
1 easter court, suite j
owings mills MD 21117
MDR Report Key8439630
MDR Text Key139544506
Report NumberMW5085050
Device Sequence Number4
Product Code FSA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/20/2019
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberTUL3510XH
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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