MAUDE Adverse Event Report: ARJOHUNTLEIGH, INC ROTOPRONE

Model Number 209500

Device Problems Sticking (1597); Positioning Problem (3009)

Patient Problems Death (1802); Tachycardia (2095)

Event Date 01/28/2015

Event Type  Death  

Event Description

On (b)(6) 2014, a pt was in the prone position and began to decompensate.The nurse pushed the automatic cpr button to rotate the pt into supine position so the pt could be treated for the tachycardia.When the bed reached 62 degrees, the bed stopped because of an open hatch alarm.The bed was them manually brought to the supine position.It has been stated that the bed was very difficult to rotate and temporarily became stuck half-way between the supine and prone position, delaying cpr initiation for an unk amount of time.The nurses were eventually able to rotate the bed to the supine position to initiate cpr.It is unk whether the pt was given cpr in the rotoprone bed or whether the pt was moved to another bed for cpr, however it is known that the pt was revived and was in a different bed when the replacement rotoprone bed was delivered.On (b)(6) 2014 at 10 am the pt died.In the nurses opinion, the delay in cpr from the bed not rotating to the supine position definitely contributed to the pt's death.Ref mfr #3009988881-2015-00011.

• Brand Name: ROTOPRONE
• Manufacturer (Section D): ARJOHUNTLEIGH, INC; 4958 stout dr; san antonio TX 78219
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 4559713
• MDR Text Key: 16540441
• Report Number: 1419652-2015-00073
• Device Sequence Number: 1
• Product Code: IKZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death