FDA Adverse Event Malfunction Summary report: N

SKINTACT

MDR report key: 4491334 · Received January 30, 2015

Report

Report Number: 8020045-2015-00010
Event Type: Malfunction
Date Received: January 30, 2015
Report Date: January 29, 2015
Manufacturer: LEONHARD LANG GMBH
Product Code: MKJ
PMA / PMN Number: K081371
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS SENT TO THE FDA AS PART OF CORRECTIVE ACTION TO AN OBSERVATION MADE DURING FEI #(B)(4) AND CONCERNS OUR COMPLAINT # (B)(4). THE CUSTOMER RETURNED A SAMPLE FROM THE SAME LOT. NO DEVIATIONS WERE DETECTED WHEN THIS SAMPLE WAS TESTED. THE DEVICE WAS WITHIN SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED WE CONCLUDE THAT THE ELECTRODE PERFORMED WITHIN SPECIFICATION.

Description of Event or Problem · 1

ON (B)(6) 2014, WE HAVE BEEN INFORMED BY (B)(6), ABOUT A POTENTIAL MALFUNCTION OF A DEFIBRILLATION ELECTRODE DF32 LOT # 31120-0772. THE PRODUCT WAS TESTED IN (B)(6) FOR USE WITH A PHILIPS DEFIBRILLATOR XL+. THE CUSTOMER REPORTED "THE EQUIPMENT DID NOT RECOGNIZE THE ELECTRODES". IT WAS ALSO STATED IN THE INITIAL REPORT THAT THE CUSTOMER USED THE FOLLOWING EQUIPMENT: HEARTSTART XL+ NGMB 059420 REF: 861290 SN (B)(4); HEARTSTART XL+ 058945 REF: 861280 SN (B)(4) AND CABLE ADAPTEUR REF: M3508A." NO HARM TO A PATIENT WAS REPORTED. WHEN THE HOSPITAL RECEIVED OTHER SKINTACT DEFIBRILLATION ELECTRODES (MODELS DF 32 AND DF27N) FROM THE DISTRIBUTOR, THESE PERFORMED FINE. THE HOSPITAL STAFF THEREFORE REPEATED THE TEST ON THE COMPLAINED PRODUCT, WHICH ALSO PERFORMED FINE THIS TIME. IN AN EMAIL DATED (B)(6), THE HOSPITAL STATED (MRS. (B)(6)) "IT IS POSSIBLE THAT THERE WERE SOME HANDLING PROBLEMS WHEN THE FIRST TESTS WERE CONDUCTED."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
70728	SKINTACT	MULTIFUNCTION DEFIBRILLATION ELECTRO	MKJ	LEONHARD LANG GMBH	DF27N	31120-0772

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA		Other