MAUDE Adverse Event Report: ARJOHUNTLEIGH INC. KINAIRMEDSURG

Device Problems Device Alarm System (1012); Inadequate or Insufficient Training (1643)

Patient Problems Death (1802); Fall (1848); Laceration(s) (1946); Myocardial Infarction (1969)

Event Date 03/22/2014

Event Type  Death  

Event Description

On (b)(6) 2014, the following was reported to arjohuntleigh by the facility's biomedical engineer.A pt had fallen from a bed and has expired.On (b)(6) 2014, arjohuntleigh received a communication from the facility's release of info supervisor with the following info regarding the event: on (b)(6) 2014, (b)(6) year old male pt was found on the floor next to the bed.The pt was weak and unable to move very well and was on a heart monitor and oxygen.It was noted at the time that three side rails were in the up position (both pt head rails and the right pt foot rail) the left pt foot rail was in the down position.The mattress was deflated due to an unk reason.A c-collar and back board were placed on the pt to prevent any further injuries.The pt had a small laceration to his head.The pt was taken to radiology for a ct scan of the head and standard x-rays.The pt subsequently suffered a cardiac arrest and died.It was undetermined if the cardiac arrest was related to the fall or trauma from the fall.The facility's staff reported that they did not know how to set the bed's exit alarm or where the alarm was located.No one at the facility reported hearing an alarm.After eval of the device and a complete investigation by the mfr, a supplementary report will be submitted.

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.Additional info will be provided upon conclusion of the mfr's investigation.

• Brand Name: KINAIRMEDSURG
• Manufacturer (Section D): ARJOHUNTLEIGH INC.; 12625 wetmore rd. suite # 308; san antonio TX 78247
• Manufacturer (Section G): ARJOHUNTLEIGH, INC.; 12625 wetmore road, suite # 308; san antonio TX 78247
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste # 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3766414
• MDR Text Key: 4464641
• Report Number: 3010048749-2014-00050
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/03/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 92