MAUDE Adverse Event Report: BLUE CHIP MEDICAL 7-11 SUFFERN PI#2, SUFFERN, NY 1 AIR PRO; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problems Material Puncture/Hole (1504); Unintended Deflation (4061)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The caller spoke with tech services and not with cscs.The caller stated the air mattress will deflate due to the fact it keeps getting holes.The caller stated the mattress is an air pro blue chip.The consumer will call her provider back for the appropriate manufacture contact information.No injury or property damage mentioned.The patient is in the bed.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AIR PRO
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): BLUE CHIP MEDICAL 7-11 SUFFERN PI#2, SUFFERN, NY 1
• MDR Report Key: 17532064
• MDR Text Key: 321444443
• Report Number: MW5138974
• 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: 07/01/2016

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