FDA Adverse Event Malfunction Summary report: N

DESK TOP GS PS US POWER CORD

MDR report key: 2921871 · Received January 15, 2013

Report

Report Number: 3008785455-2013-00007
Event Type: Malfunction
Date Received: January 15, 2013
Date of Event: December 1, 2012
Report Date: December 28, 2012
Manufacturer: HOSPIRA INC.
Product Code: FRN
PMA / PMN Number: K060806
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED MELTING. ON AN UNSPECIFIED DATE, THE AC POWER ADAPTER WAS CONNECTED TO A GEMSTAR PUMP AND WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME, THE ANESTHESIOLOGIST NOTED THAT THE GEMSTAR PUMP WAS OPERATING ON BATTERY POWER INSTEAD OF THE INTENDED AC POWER. AT THIS TIME, THE ANESTHESIOLOGIST REPORTED SMOKE AND MELTING WAS NOTED AT THE CONNECTION OF THE AC POWER CORD PLUG AND THE TRANSFORMER OF THE AC POWER ADAPTER. IT WAS REPORTED THAT THE AC POWER ADAPTER WAS DISCONNECTED FROM THE GEMSTAR PUMP AND REMOVE FROM CLINICAL USE. THE THERAPY WAS RESUMED USING THE SAME GEMSTAR PUMP. THERE WERE NO REPORTED ADVERSE PT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PT. NO MEDICAL INTERVENTIONS WERE REQUIRED. DURING VISUAL EXAMINATION OF THE AC POWER ADAPTER AT THE USER FACILITY, ONE OF THE THREE BLADES ON THE TRANSFORMER WAS MELTED AND BROKEN OFF. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
22572	DESK TOP GS PS US POWER CORD	80FRN	FRN	HOSPIRA INC.	NA	11121G1

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			GEMSTAR PUMP: LIST #13088, SN (B)(4)