FDA Adverse Event Other Summary report: N

90088740 DATASCOPE PANORAMA AD TELE

MDR report key: 2712941 · Received August 20, 2012

Report

Report Number: 1282497-2012-00021
Event Type: Other
Date Received: August 20, 2012
Report Date: July 31, 2012
Manufacturer: LHI TECHNOLOGY
Product Code: MHX
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. ATTEMPTS TO RETRIEVE ADDITIONAL INFO WERE MADE TO (B)(6). ON (B)(6) 2012, (B)(6) STATED THAT SHE BELIEVED THE KENDALL DL ADAPTER WAS IN USE ON THE PT AT THE TIME OF DEATH. (B)(6) ALSO STATED THAT SHE WAS NOT ABLE TO PROVIDE ANY FURTHER INFO REGARDING THIS INCIDENT AS THIS WAS AN ON-GOING INVESTIGATION AT THEIR FACILITY. IF ADDITIONAL INFO IS OBTAINED, THE MEDWATCH FORM WILL BE UPDATED.

Description of Event or Problem · 1

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012, THAT A CUSTOMER HAD AN ISSUE WITH A KENDALL DL ADAPTER. THE CUSTOMER REPORTS THAT THE KENDALL DL ADAPTER PROVIDED LOW SIGNAL STRENGTH. THE CUSTOMER FURTHER STATED THAT THE PT EXPIRED; HOWEVER, THEY ARE UNABLE TO CONFIRM IF THERE IS ANY CORRELATION BETWEEN THE KENDALL DL ADAPTER AND THE PT DEATH.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	90088740 DATASCOPE PANORAMA AD TELE	DL ADAPTER	MHX	LHI TECHNOLOGY	33527	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other