MAUDE Adverse Event Report: HILL-ROM CLINITRON BED

Model Number HITE-RITE

Device Problem Electromagnetic Interference (1194)

Patient Problem Electric Shock (2554)

Event Date 01/18/2015

Event Type  Injury  

Event Description

Hill-rom clinitron "sand" bed was determined to be interfering in other electrical devices and biomedical equipment in proximity.Examples include malfunction of baxter iv pumps, pt television remote and nurse cell phone.Pt also complained of "little shocks" when being repositioned.By process of elimination, swapping out the iv pumps, the bed and moving the pt to another room, we determined that the bed was the source of interference.The hill-rom svc tech "(b)(4), replaced the bed with another, once were determined that the pt rooms and other equipment were not the source.The call bell was in proximity to the bed in question.

• Brand Name: CLINITRON BED
• Type of Device: CLINITRON BED
• Manufacturer (Section D): HILL-ROM; batesville
• MDR Report Key: 4466307
• MDR Text Key: 5398657
• Report Number: MW5040456
• Device Sequence Number: 1
• Product Code: INX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2015

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: Health Professional
• Device Model Number: HITE-RITE
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BAXTER IV PUMPS X2
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR