MAUDE Adverse Event Report: KAP MEDICAL FREEDOM MEDICAL CONVERTIBLE SERIES MATTRESSES; MATTRESS, AIR FLOTATION

Device Problems Material Discolored (1170); Product Quality Problem (1506); Material Deformation (2976); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Mattresses were purchased for pt care beds beginning on (b)(6) 2017.On (b)(6) 2018, we had the first failure of the mattresses.Mattress covers became discolored in the center then continued to deteriorate with horizontal and vertical tears.Company was contacted as numerous mattresses were deteriorating.At first we were informed it was the cleaning solution, then it was that the mattress was not dried enough before putting sheets on, then it was how the mattress was positioned, and that we were the only hosp experiencing this type of event.New covers were issued to us costing $25,900, made of the same material and again, the covers deteriorated and tore.These mattresses do not withstand the activities related to pt care, support our pt care needs, and are of poor quality.The company has come out with a different material for a new cover - unsure how long that will last.Since (b)(6) 2017, we have had to replace 74 mattresses due to these quality issues.

• Brand Name: FREEDOM MEDICAL CONVERTIBLE SERIES MATTRESSES
• Type of Device: MATTRESS, AIR FLOTATION
• Manufacturer (Section D): KAP MEDICAL; 1395 pico street; corona CA 92881
• MDR Report Key: 7818549
• MDR Text Key: 118470410
• Report Number: MW5079392
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1