MAUDE Adverse Event Report: LINETAMERICAS LINET AMERICAS; LINET BEDS

Model Number 1MC5A650-31

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problems Death (1802); Fall (1848); Head Injury (1879); Incontinence (1928); Laceration(s) (1946); Low Oxygen Saturation (2477); Blood Loss (2597)

Event Date 10/25/2017

Event Type  Death  

Event Description

At 0825, rn made hourly rounds down the hall, passing daily plans.Veterans was in bed and bed was in low position, head of bed elevated.Rn continued daily tasks by reporting to provider.At approximately 0855, veterans call light went off.Lpn entered room to find veteran on the floor.Staff reported that they needed assistance, and from the provider office rn heard "help, i need an rn".Rn ran down hall, directed toward the veteran's room by msa.Upon entering the room, one rn, one cna and one lpn was present.Veteran's bed was seen in a tilted position towards the window.Veteran was face down on the ground with his head on the base of the kangaroo pump pole.There was a small amount of blood on the floor under the pole base.Rn went to notify provider of situation, and ran back to the room.Veteran was rolled onto back with neck support.A sling was placed under the veteran and pressure was applied to wound on the forehead.Provider completed a neurological assessment and stated that we could move veteran back to bed.Bed was replaced.Veteran was placed in bed.Full set of vital signs was taken by rn.Full passive range of motion was performed, and veteran denied any pain associated with movement.Wound care was provided to forehead and toe per provider order.Veteran was placed with head of bed at 15 degrees, peg tube feeding was held.Veteran placed on 2 liters of oxygen via nasal cannula for low oxygen saturation.Two cna's entered room to perform routine morning care, rn stepped out of room to gather supplies.Veteran call light went on, rn returned to room immediately.Veteran had experienced loss of control of bowel, and had vomited.The emesis was yellow in color with emulsions throughout.Veteran head of bed was elevated at the time of vomiting.Rn provided oral suctioning to veteran to remove residual from oral cavity.Rn brushed veteran's teeth.Veteran's linens were replaced and rn remained at bedside with veteran.Rn was seated at right side of bed, holding the veteran's hand.Veteran's hand pronated, fingers tensed, tongue thrusted and drooled from mouth, and breathing became diaphragmatic.The symptoms occurred over less than ten seconds.Each time, respiratory rate returned to baseline.Provider and nurse manager stepped in and out of the room several times throughout the time that rn was present at bedside, requesting updates and providing further support.At approximately 130 pm, lpn arrived to front desk and requested that rn go down to look at veteran's breathing.Upon arrival, veteran had no visible chest rise or fall.Veteran's apical pulse was auscultated for one full minute, no visible chest rise and fall over one full minute.Provider was notified and called time of death at 1336.

• Brand Name: LINET AMERICAS
• Type of Device: LINET BEDS
• Manufacturer (Section D): LINETAMERICAS; charlotte NC
• MDR Report Key: 7048102
• MDR Text Key: 92651542
• Report Number: MW5073417
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1MC5A650-31
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: KANGAROO PUMP: KENDALL KANGAROO PUMP, TYCO HEALTHCARE. ; MATTRESS: SIZEWISE SAPPHIRE 1100
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Weight: 89