MAUDE Adverse Event Report: KAP MEDICAL TURNCAIR LR SYSTEM; PATIENT AIR MATTRESS

Model Number TCLR-3680-M

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Fall (1848)

Event Date 04/16/2018

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end user, per the end user, patient fell out of bed and sustained bumps/bruises.The patient was checked by staff doctor and received x-ray/ct scan.Both scans were negative.(b)(4) were entered into our system to have the mattress and control unit returned to joerns for investigation.As of this writing, the mattress and control unit have not been returned.

• Brand Name: TURNCAIR LR SYSTEM
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): KAP MEDICAL; 1395 pico street; corona CA 92881
• Manufacturer (Section G): KAP MEDICAL; 1395 pico street; corona CA 92881
• Manufacturer Contact: felicia banks ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 7448096
• MDR Text Key: 106141564
• Report Number: 3009402404-2018-00022
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/20/2018

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: TCLR-3680-M
• Device Catalogue Number: TCLR-3680-M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization