MAUDE Adverse Event Report: UNKNOWN; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Device Problems Noise, Audible (3273); Unintended Deflation (4061)

Patient Problem Pain (1994)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

Patient heard a popping noise.Air mattress suddenly deflated.Patient complaining of pain.Company sent a representative to the hospital to repair the bed.

• Brand Name: UNKNOWN
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• MDR Report Key: 15878755
• MDR Text Key: 304509564
• Report Number: 15878755
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20805 DA
• Patient Sex: Female
• Patient Weight: 184 KG