MAUDE Adverse Event Report: MC HEALTHCARE PRODUCTS MAXIM,; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Unintended Deflation (4061)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Per provider: deflated dolphon mattress while patient was away for 2 days at the hospital.Wires on the auto vector were exposed causing a possible short.Cord could have been pulled too hard.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: MAXIM,
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): MC HEALTHCARE PRODUCTS
• MDR Report Key: 17527690
• MDR Text Key: 321350336
• Report Number: MW5134622
• 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: 07/01/2015

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
• Treatment: FNL AIR FLOTATION, ALTERNATING PRESSURE