FDA Adverse Event Malfunction Summary report: N

MAXXIM MEDICAL

MDR report key: 192353 · Received October 7, 1998

Report

Report Number
MW1014763
Event Type
Malfunction
Date Received
October 7, 1998
Date of Event
October 1, 1998
Report Date
October 5, 1998
Manufacturer
MAXXIM MEDICAL, INC. ARGON DIVISION
Product Code
DRS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

WHEN AN INVASIVE PRESSURE MONITORING KIT IS HOOKED UP TO THE PT AND MONITOR, THERE IS NO PRESSURE MONITORING AVAILABLE, SOME TIMES THERE IS INTERMITTENT MONITORING. SOMETIME THE PRESSURE SHIFTS OFF THE SCALE. THERE HAVE BEEN VARIOUS SITES AND DIFFERENT MONITORS WHERE THIS PROBLEM HAS OCCURRED. THE PROBLEM BEING THE WAVEFORM (PRESSURE) DISSAPPEARS, CAUSING THE DATEX AS3 MONITOR TO RECOGNIZE NO INPUT, THEREBY ELIMINATING THE PRESSUE SCALES. THIS HAS BEEN THE CASE ALSO IN FACILITY'S INTENSIVE CARE/CRITICAL CARE UNITS, AND PRE-OPERATIVE AREA. VARIOUS STAFF BELIEVE THE PROBLEM TO BE THE CABLE IN BETWEEN THE MONITOR AND THE PRESSURE TRANSDUCER. FOR THE PAST MONTH STAFF HAVE BEEN RECEIVING INTERFACE CABLES MARKED DEFECTIVE. AFTER TESTING, NO CABLE PROVED TO BE DEFECTIVE. FINALLY STAFF GOT A TRANSDUCER THAT WAS GIVING PROBLEMS. AFTER TESTING IN THE BIOMED SHOP, THE TRANSDUCER PROVED TO BE DEFECTIVE; DUPLICATING THE EXACT PROBLEM THAT THE STAFF WAS COMPLAINING ABOUT. RPTR X-RAYED THE SUSPECTED TRANSDUCER AND DID NOT CONCLUDE MUCH. RPTR DISSASSEMBLED A GOOD TRANSDUCER AND SUSPECTED THE PROBLEM TO LIE BETWEEN THE CONTACT OF THE BRIDGE AND TO THE GOLD LEAD ON THE FOAM, OR ELSE THE GOLD LEAF ON THE FOAM TO THE WIRE INPUT. RPTR SUSPECTS AN INTERMITTENT OPEN, THEREBY CAUSING THE MONITOR NOT TO RECOGNIZE A PRESSURE INPUT. RPTR GAVE THE BAD TRANSDUCER TO ANOTHER STAFF MEMBER. THE PLASTIC IS CRACKED BECAUSE RPTR'S CO WORKER HAD "SHOT IT WITH FOAM". IT STILL WILL FAIL IF ONE BANGS IT AROUND.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MAXXIM MEDICAL INVASIVE MONITORING KIT DRS MAXXIM MEDICAL, INC. ARGON DIVISION 041-574-505A 98091999

Patients

Seq Age Sex Outcome Treatment
1 *