MAUDE Adverse Event Report: KAP MEDICAL LOW AIR LOSS MATTRESS, 36 X 80 X 10 9153647223; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number NA:MA80

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/06/2019

Event Type  Injury  

Manufacturer Narrative

There is no allegation of malfunction or defect with the bed or mattress.The reporter advised that the parameters for the residents' weight were not set prior to the patient being placed in the bed.Per invacare tech not setting the correct parameters may cause the middle of the bed to sag.No rails were on the bed.Per the facility¿s policy, bedrails are not used on beds of patients having dementia.Invacare attempted to get further information on the pt.¿s fractures and treatment without success.The case is being investigated by the facility and no further information is being released currently.The cause of the fall is unknown.Should additional information become available, a supplemental record will be filed.

Event Description

The patient was in a facility using an ma80 low air loss mattress, and she fell out of bed within 10 minutes of initial placement.The patient sustained unknown fractures.

• Brand Name: LOW AIR LOSS MATTRESS, 36 X 80 X 10 9153647223
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): KAP MEDICAL; 1395 pico st; corona CA 92881
• MDR Report Key: 9417581
• MDR Text Key: 169276996
• Report Number: 1531186-2019-00008
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/05/2019,11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NA:MA80
• Device Catalogue Number: MA80
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Nursing Home
• Date Report to Manufacturer: 12/05/2019
• Date Manufacturer Received: 12/04/2019
• 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): Other