MAUDE Adverse Event Report: JOERNS HEALTHCARE TURNCAIR; PATIENT AIR MATTRESS

Model Number TURNCAIR

Device Problem Deflation Problem (1149)

Patient Problem Fall (1848)

Event Date 09/25/2023

Event Type  malfunction  

Event Description

It was reported to the manufacturer, by the end user, per the end user, that was the patient been cared for at the time of the incident.Clinical advisor to confirm.· was the patient transferring from bed to another piece of equipment - standard etc? no, since the initial report, 2 members of hospital staff have reported that the patient was sat on the edge of the mattress and the mattress was sunken in slightly underneath her.Ward staff were unable to confirm what settings the asu was on at the time.The patient then [?]launched' herself off the bed - the 2 staff that were present at the time described this as a [?]behavioural issue' and have made witness statements.· did the patient fall backwards or forwards? i believe the patient fell forwards, however i will ask our clinical advisor to confirm.· is the turncair surface and air supply unit still working correctly.Both are working correctly.· if no - what fault is apparent with the product and was this before or after the incident occurred.N/a.· when was the last service inspection conducted on the turncair in question.It was last inspected and function checked on 02/10/2023.(b)(4).

Manufacturer Narrative

This report or other information submitted by joerns healthcare under 21 cfr part 803, and release by fda of that report information, does not reflect a conclusion or admission by joerns healthcare , its employees, its contract service firms, or their employees, finished device suppliers, or their employees caused or contributed to the reportable event.

• Brand Name: TURNCAIR
• Type of Device: PATIENT AIR MATTRESS
• Manufacturer (Section D): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer (Section G): JOERNS HEALTHCARE; avenida pedro hinojosa no. 26; cuidad industrial; matamoras, tamaulipas 87499 ; MX 87499
• Manufacturer Contact: mackenzie bay ; 2100 design road; arlington, TX 76014 ; 8008260270
• MDR Report Key: 18192612
• MDR Text Key: 328811049
• Report Number: 3009402404-2023-00041
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TURNCAIR
• Device Catalogue Number: TURNCAIR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other