MAUDE Adverse Event Report: SENTECH MEDICAL SYSTEMS; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Catalog Number SQU1336

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 04/29/2021

Event Type  malfunction  

Event Description

I noticed that the air mattress did not seem to be fully inflated, so i looked at the power box at the foot of the bed.There were no numbers lit up on the power box, however, the on/off switch was in the ¿on¿ position.I flipped the switch from on to off and back to on again when the numbers lit up and air began to float again into the mattress.The patient was then hoyer lifted into the chair, we talked for a while as we waited for the bed to inflate again and then the patient was lifted back into the bed.

• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): SENTECH MEDICAL SYSTEMS; 5353 nw 35th avenue ft.; lauderdale FL 33309
• MDR Report Key: 11912454
• MDR Text Key: 253509488
• Report Number: 11912454
• 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: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: SQU1336
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Weight: 130