FDA Adverse Event Injury Summary report: N

AIR EXPRESS LAL

MDR report key: 3519185 · Received December 6, 2013

Report

Report Number
MW5033343
Event Type
Injury
Date Received
December 6, 2013
Date of Event
October 31, 2013
Report Date
December 5, 2013
Manufacturer
GAYMAR/PLEXUS
Product Code
FNM
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PLACED ON AIR MATTRESS THAT AFTER SEVERAL HOURS PT COMPLAINED FELT "HOT". STAFF EVALUATED, NOTED WARM AIR BEING BLOWN BY MATTRESS AND DEFLATED IT FOR A PERIOD OF TIME. LATER RE-INFLATED, SAME COMPLAINT, MATTRESS REMOVED AND RETURNED TO RENTAL COMPANY. PT DISCHARGED 2 DAYS LATER, THEN STATE PT HAD BLISTERS FORM AND BREAK ON FRAGILE LOWER EXTREMITIES WHERE SHE TOUCHED THE MATTRESS. PHOTOS NOT TAKEN UNTIL 2 DAYS AFTER DISCHARGE SHOW BLISTERS IN STAGES OF FORMATION AND BREAKING. ACCORDING TO FAMILY, PT IS UNABLE TO ALLOW LINENS TO TOUCH THE LEGS. RENTAL COMPANY PROVIDED A TEST SHEET AT DELIVERY SHOWING THE MOTOR PERFORMING WITHIN NORMAL LIMITS. UPON RETURN TO THEM, THE RENTAL COMPANY, UNIVERSAL HOSPITAL SERVICES (DHS), NOTED THE PRESSURE COULD NOT BE CONTROLLED BY THE CONTROL KNOB, AND THE CONNECTOR HOSE "WAS WARM TO THE TOUCH". PT WORE SEQUENTIAL COMPRESSION DEVICES ON LOWER LEGS BRIEFLY DURING HER STAY. NO MODEL MFR AVAILABLE. MEDICATIONS: CLONAZEPAM 0.5 MG TWICE DAILY; TYLENOL, PREDNISONE AND BENADRYL ONCE, PRIOR TO BLOOD TRANSFUSION; PEPCID 20 MG DAILY; SYNTHROID 75 MCG 1 TABLET DAILY; FLAGYL 500 MG IVPB Q8; PROTONIX 40 MG DAILY; DUONEB NEBULIZER RX QID; LOMOTIL 2 TABS QID; PRN DIARRHEA; NOREPINEPHRINE 4MG/250CC D5W DRIP TITRATE TO MAP >65MM HG; TRANSFUSED 2 UNITS PRBC'S. OTHER MEDS TAKEN AT HOME, BUT NOT IN HOSPITAL: AMLODIPINE AND BENAZEPRIL 5/10 TABLET DAILY; LASIX 20 MG ONCE DAILY; PHENERGAN 25 MG Q. 4H P.R.N.; VICODIN 325/5 MG 1 TABLET Q. 4H P.R.N.; ELAVIL 25 MG AT BEDTIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
633824 AIR EXPRESS LAL CONTROL DEVICE FNM GAYMAR/PLEXUS P/1500C
633825 AIR EXPRESS LOW AIR LOSS OVERLAY MATTRESS OVERLAY FNM GAYMAR/PLEXUS P200

Patients

Seq Age Sex Outcome Treatment
1 80 YR Required Intervention SEQUENTIAL COMPRESSION DEVICE