SMITH & NEPHEW, INC. MOT DR UNIT HNDCONT POWERMAX ELITE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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Model Number 72200872 |
Device Problems
Overheating of Device (1437); Mechanical Jam (2983)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Event Description
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It was reported that, the "mdu powermax elite shaver" was stalling and getting hot.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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Internal complaint reference: (b)(4).The reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the exterior of product and no physical damage was observed.Mdu failed functional tests with motor stall and overheating of cord.After troubleshooting, the cause of the overheating was observed to be a defective power cord assembly.It was determined that the power cord has shorted internal wiring.The complaint investigation has concluded that this unit has succumbed to physical damage to power cord.Factors which can contribute to a shorted power cord include rolling a heavy cart over the cord or excessive bending of the cord.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.
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Search Alerts/Recalls
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