MAUDE Adverse Event Report: AIRFLO (XIAMEN) MEDICAL CO., LTD. DRIVE; MATTRESS

Model Number 14508

Device Problem Device Issue (2379)

Patient Problem Pressure Sores (2326)

Event Date 08/28/2016

Event Type  Injury  

Event Description

Drive devilbiss healthcare received complaint from a patient using a low air loss mattress that drive devilbiss healthcare imports and distributes.Patient claims the center part of the bed does not inflate which allegedly caused bed sores.Mattress is being returned for evaluation, dme provider sent replacement foam mattress to the customer.This information was provided by melinda thompson (contact).

• Brand Name: DRIVE
• Type of Device: MATTRESS
• Manufacturer (Section D): AIRFLO (XIAMEN) MEDICAL CO., LTD.; 4f no. 6, east haijian road; haicang, xiamen fujian 36102 6; CH 361026
• MDR Report Key: 6022628
• MDR Text Key: 57162525
• Report Number: 2438477-2016-00049
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/12/2016,09/12/2016

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: No Information
• Device Model Number: 14508
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2016
• Distributor Facility Aware Date: 09/12/2016
• Date Report to Manufacturer: 10/12/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR
• Patient Weight: 46