MAUDE Adverse Event Report: HILL-ROM, INC. ACCUMAX QC COMPLETE; BED FLOTATION THERAPY POWERED

Model Number PAISF9310384

Device Problem Inflation Problem (1310)

Patient Problem Wound Dehiscence (1154)

Event Date 05/29/2014

Event Type  Other  

Event Description

Hill-rom received a report from the account stating the mattress is not inflating and the patient has developed open wounds.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The hill-rom technician found the sacrum area of the mattress was not as firm as the rest of the mattress and the foam has lost its resiliency.The patient has developed an unstageable deep tissue injury.The technician replaced the mattress to resolve the issue.The patient was treated with ointments and dressings but no surgery was required.He was released from the hospital on (b)(6) 2014.An engineering investigation will be performed.The investigation is ongoing, however, if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

• Brand Name: ACCUMAX QC COMPLETE
• Type of Device: BED FLOTATION THERAPY POWERED
• Manufacturer (Section D): HILL-ROM, INC.; batesville IN
• Manufacturer Contact: john cummings ; 1069 state route 46 east; batesville, IN 47006 ; 8129312869
• MDR Report Key: 3912343
• MDR Text Key: 15122192
• Report Number: 1824206-2014-01849
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PAISF9310384
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2014
• Initial Date FDA Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other