MAUDE Adverse Event Report: CARILEX MEDICAL, INC.; LOW AIR LOSS MATTRESS

Model Number SR309

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Strangulation (2084)

Event Type  Death  

Event Description

Daughter found patient had slid between the side rail and bed.Pressure was noted on her throat from the side rail.Daughter released the side rail and the patient slid to the floor.Daughter and paramedics attempted cpr without success and patient was pronounced at 12:23 p.M.

Manufacturer Narrative

(b)(4).There was no information provided in the mdr that indicated the product of the airodyne mattress system, controller serial number (b)(4), malfunctioned in any way only that it was present at the time of the event.After having insight into the event and investigation, we do not think that the product of the airodyne mattress system contributed in any to the death of the patient or malfunctioned in any way.The device history record of the airodyne mattress system has been reviewed and determined that the device was manufactured, tested and released according to established procedures/specifications.It is also verified that all established release criteria were met and there were no deviations or issues observed in the records.

• Type of Device: LOW AIR LOSS MATTRESS
• Manufacturer (Section D): CARILEX MEDICAL, INC.; guishan townership (333); taoyuan county ; TW
• Manufacturer Contact: no. 77 kaji 1st road; guishan township (333); taoyuan county
• MDR Report Key: 3590982
• MDR Text Key: 4191377
• Report Number: 9710603-2013-00001
• 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: Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SR309
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2013
• 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
• Treatment: PRESSURE RELIEF MATTRESS
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Weight: 59