MAUDE Adverse Event Report: CAREMED MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Defective Device (2588)

Patient Problem Impaired Healing (2378)

Event Date 11/01/2017

Event Type  Injury  

Event Description

Joerns healthcare received the included information.The device(s) in question was not manufactured nor imported by joerns healthcare, per section 803.22 (b) (2) we are submitting the following information.Caremed, the manufacturer of the device involved in the incident was notified by joerns on november 29, 2017.The medwatch report (mw5073187) was forwarded to caremed on november 29, 2017.The mattress was found to be at the highest setting in the a.M.Causing the pressure ulcer to get worse.The wound nurse(meg) found the setting in the a.M., tried to change and setting would not change.Technician was called in.Turned the control unit off and on and unit re-set.The pressure ulcer got better after that.The patient is still on the mattress.Injury listed; pressure ulcer got worse.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): CAREMED
• MDR Report Key: 17532955
• MDR Text Key: 321148623
• Report Number: MW5139861
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2017

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1