MAUDE Adverse Event Report: SPAN AMERICA PRESSURE GUARD APM; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problem Inability to Auto-Fill (1044)

Patient Problem Tissue Breakdown (2681)

Event Type  Injury  

Event Description

The mattress will not fill up- apria came out and because the prescription was for the bed and not the mattress they wouldn't leave the mattress.She stated that her father has not his mattress working for a month.He is getting bed sores on his buttocks and his back, he had a liver transplant and he doesn't heal well.She will go to her fathers house on her lunch and call us back to troubleshoot and give us a serial number.She knows the bed is invacare but she does not have any information on the air mattress.A return was not issued being we do not know if it is a invacare product yet.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PRESSURE GUARD APM
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): SPAN AMERICA
• MDR Report Key: 17535822
• MDR Text Key: 321148724
• Report Number: MW5142717
• 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: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1