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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.) SAPPHIRE PULSE BLOWER; ALTERNATING PRESSURE AIR FLOTATION MATTRESS
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RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.) SAPPHIRE PULSE BLOWER; ALTERNATING PRESSURE AIR FLOTATION MATTRESS Back to Search Results
Model Number SFPULB
Device Problems Inflation Problem (1310); Overheating of Device (1437)
Patient Problem Pressure Sores (2326)
Event Date 12/24/2018
Event Type  Injury  
Manufacturer Narrative
Customer initially reported that blower is not working properly and mattress is not staying inflated; and that the device required service.During follow-up, customer reported that blower would get hot and then would go off until it cooled down, and that this happened repeatedly.Customer reported patient required hospitalization as a result of pressure injury sustained.A review of pre-delivery inspection records found the device received and passed appropriate inspections prior to release.A review of service records found no reports of the customer requesting service prior to this report.Due to billing non-payment issues, the distributor had previously unsuccessfully attempted to retrieve the device from the customer.Post-incident inspection of the device found that the air filter on the blower was dirty consistent with prolonged use without routine maintenance.Inspection of the mattress and blower otherwise found the devices to be in good condition.After replacement of the air filter, testing of the device found it to be working as designed with no malfunctions found.The sapphire user manual provides instructions, schedules, and warnings related to routine maintenance for the device.Users are cautioned "caution: the mattress and control unit requires regular maintenance to ensure performance and avoid premature wear, damage and injury." multiple places in the manual state "control unit air filters must be cleaned weekly." and "replacement of the filter is recommended every 6 months." the manual provides instructions on how to properly clean the air filter.Troubleshooting advice in the manual states "if mattress is not inflating:.Check or clean air filters." our investigation found that the reported issue was consistent with the blower overheating as a result of the customers' failure to ensure routine maintenance on the device's air filter was performed, precluding the mattress from consistently keeping the mattress appropriately inflated.
 
Event Description
Customer initially reported that blower is not working properly and mattress is not staying inflated; and that the device required service.During follow-up, customer reported that blower would get hot and then would go off until it cooled down, and that this happened repeatedly.Customer reported patient required hospitalization as a result of pressure injury sustained.
 
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Brand Name
SAPPHIRE PULSE BLOWER
Type of Device
ALTERNATING PRESSURE AIR FLOTATION MATTRESS
Manufacturer (Section D)
RAYES INC. (D/B/A SUNFLOWER MEDICAL L.L.C.)
206 jefferson st.
ellis KS 67637
Manufacturer (Section G)
RAYE'S INC. (D/B/A SUNFLOWER MEDICAL L.L.C.)
206 jefferson st.
ellis KS 67637
Manufacturer Contact
nicholas rose
500 commerce pkwy
hays, KS 67601
8168415391
MDR Report Key8271608
MDR Text Key133936151
Report Number0001931307-2019-00001
Device Sequence Number1
Product Code FNM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
E523279
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Remedial Action Inspection
Type of Report Initial
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSFPULB
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/24/2018
Date Manufacturer Received12/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age65 YR
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