MAUDE Adverse Event Report: HILL-ROM COMPANY, INC. CLINITRON; BED, AIR FLUIDIZED

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Pain (1994)

Event Date 07/07/2014

Event Type  malfunction  

Event Description

The patient was on a hill-rom clinitron bed due to having had a surgical skin graft.The bed was being used to promote wound healing.The patient's nurse and physical therapist deflated the bed to allow the therapist to assist the patient to sit at the edge of bed.The bed was turned off.When the nurse attempted to turn clinitron bed back on, 45 minutes later, an error message was read.The error message indicated that the bed overheated and that the bed temperature was high.The nurse attempted to trouble-shoot by restarting the bed / plugging the bed in and out, but this was without success.The hill-rom company was called and they reported that they paged the technician.We telephoned hill-rom again two times, both times reporting that the technician had been paged.The technician arrived to the inpatient floor two and a half hours after the bed had been turned off.On arrival, the technician assessed the bed and explained the results of the error messages.Although room temp was less than 75 degrees (bed parameters state that the temperature must be less than 75 degrees), bed can overheat if the ambient temperature becomes too warm.The room temperature was turned down by nursing.The hill-rom clinitron bed was reset by the technician using a button under the bed.The bed then re-inflated.The technician also checked filter and system within the bed.Technician reported no issue with bed, only temperature.Technician did not believe bed needed to be changed.The problem that this created was that while the bed remained deflated, the nurse remained at the bedside offering pillows to reduce pressure on the wound, as well as repositioning the patient frequently.The patient also required additional pain medications.The option of transferring the patient to a regular hospital bed was considered, but likely would have caused additional discomfort due to limitation and skin restrictions - the goal for this patient has been to avoid friction and shearing injuries to the skin at all costs.Manufacturer response: the hill-rom technician was on-site and repaired the bed.The concern was regarding the ambient temperature of the room and instructions regarding not to turn the bed off when it is still needed by the patient - this was unknown to the staff caring for the patient.

• Brand Name: CLINITRON
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM COMPANY, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 3983132
• MDR Text Key: 19404375
• Report Number: 3983132
• Device Sequence Number: 1
• Product Code: INX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/09/2014

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: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THE AMBIENT TEMPERATURE OF THE ROOM MAY HAVE; AFFECTED THE PRODUCT.
• Patient Age: 61 YR