CONTROL 3328200 PNEUMATIC FOOT

MDR report key: 2955527 · Received February 11, 2013

Report

Report Number: 1045254-2013-00086
Event Type: Malfunction
Date Received: February 11, 2013
Date of Event: January 13, 2013
Report Date: January 21, 2013
Manufacturer: XOMED MFG JACKSONVILLE
Product Code: ERL
PMA / PMN Number: K791407
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THIS PRODUCT IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative · 1

DEVICE RETURNED (B)(6) 2013. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION BY THE QUALITY ENGINEERING TEAM. THE PRODUCT ANALYSIS FOUND THERE WAS A PIECE OF TAPE AROUND ONE POINT OF THE CABLE. PRESSURE METER ASSET 1270-J WAS USED TO CHECK THE FOOTSWITCH. THE PEDAL WAS DEPRESSED SEVERAL TIMES; READINGS WERE BETWEEN 9 AND 10.5 PSI. PER XPI-NS 3328200 REV J SECTION 9.7.1.1, READING SHOULD BE BETWEEN 5 AND 11 PSI. WHEN THE PEDAL WAS RELEASED, THE PRESSURE WENT BACK TO ZERO. NO FUNCTIONAL ISSUES WERE IDENTIFIED DURING THE EVALUATION. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. (B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PNEUMATIC FOOT CONTROL UNINTENTIONALLY ACTIVATED. THE EVENT DID NOT OCCUR DURING A PROCEDURE AND THERE WAS NO PATIENT IMPACT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
59612	CONTROL 3328200 PNEUMATIC FOOT	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE	ERL	XOMED MFG JACKSONVILLE	3328200	0206139618

Patients

Seq	Age	Sex	Outcome	Treatment
1