MAUDE Adverse Event Report: ITO CO., LTD. TSUKUBA FACTORY SW-180; DIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT

Model Number SW-180

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 09/20/2014

Event Type  Injury  

Event Description

The patient had been receiving treatment using the subject device with 40 w output in continuous mode.The subject device burnt the patient on the hip during the thirteenth treatment.According to the hospital, the burn had fully healed by (b)(6) 2014 when ito received the information on the event.

Manufacturer Narrative

Ito examined the device history record for the device involved in the adverse event.There were no problems observed during the manufacturing or testing noted in the dhr.Only the oscillator unit was returned to ito.Ito conducted the evaluation of the returned oscillator unit but there was no output from the unit.Ito received a report describing misuse by the user and documented it in the investigation report on the subject device (s/n (b)(4)).Ito reminded the user of the correct use of the device, as described in the user manual.

• Brand Name: SW-180
• Type of Device: DIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT
• Manufacturer (Section D): ITO CO., LTD. TSUKUBA FACTORY; 3-39-14 uzurano; ami-machi; inashiki-gun, ibaraki 300-0 341; JA 300-0341
• Manufacturer (Section G): ITO CO., LTD. TSUKUBA FACTORY; 3-39-14 uzurano; ami-machi; inashiki-gun, ibaraki 300-0 341; JA 300-0341
• Manufacturer Contact: kenneth block ; 1201 richardson dr.; suite 160; richardson, TX 75080 ; 9724809554
• MDR Report Key: 6412980
• MDR Text Key: 70249580
• Report Number: 9614750-2017-00007
• Device Sequence Number: 1
• Product Code: IMJ
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K022846
• 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: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SW-180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Weight: 65