MAUDE Adverse Event Report: RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.) SW PULSATE VCR MATTRESS; SIZEWISE PULSATE VERSACARE MATTRESS

Model Number APULV

Device Problem Inflation Problem (1310)

Patient Problem Pressure Sores (2326)

Event Date 04/12/2021

Event Type  Injury  

Event Description

The patient incurred a hospital-acquired pressure injury on a sizewise versacare pulsate mattress replacement.Nursing staff noticed a deflated air cell in the patient's sacral area which they identified as the possible cause for the wound.

• Brand Name: SW PULSATE VCR MATTRESS
• Type of Device: SIZEWISE PULSATE VERSACARE MATTRESS
• Manufacturer (Section D): RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.); 206 jefferson st.; ellis KS 67637
• Manufacturer (Section G): RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.); 206 jefferson street; ellis KS 67637
• Manufacturer Contact: jason pelc ; 500 commerce pkwy; hays, KS 67601 ; 8168410101
• MDR Report Key: 12359558
• MDR Text Key: 267889753
• Report Number: 0001931307-2021-00002
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00845699000722
• UDI-Public: 00845699000722
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Nurse
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: APULV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/12/2021
• Date Manufacturer Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• 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): Hospitalization; Required Intervention
• Patient Weight: 75