FDA Adverse Event Malfunction Summary report: N

ADVANTA 2 BED

MDR report key: 3821309 · Received April 28, 2014

Report

Report Number: 3006697241-2014-00408
Event Type: Malfunction
Date Received: April 28, 2014
Date of Event: April 2, 2014
Report Date: April 2, 2014
Manufacturer: HILLROM DE MEXICO S DE RL DE CV
Product Code: FNL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE HILL-ROM TECHNICAL SUPPORT REPRESENTATIVE PERFORMED TROUBLESHOOTING OVER THE PHONE WITH THE ACCOUNT, ASKING THE ACCOUNT TO ZERO THE BED EXIT AND THEN PLACE THE PATIENT BACK IN THE BED AND WEIGHT THEM AND ATTEMPT TO SET THE PPM. PER THE HILL-ROM USER MANUAL, WARNING: THE BED EXIT ALARM SYSTEM IS NOT INTENDED AS A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE BED EXIT ALARM SYSTEM MUST BE USED IN CONJUNCTION WITH A SOUND RISK ASSESSMENT AND PROTOCOL. THE ACCOUNT DID NOT PROVIDE THE SERIAL NUMBER OF THIS BED. IT IS UNKNOWN IF HILL-ROM PERFORMED ANY PREVENTIVE MAINTENANCE. IT IS ALSO UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. HILL-ROM TECHNICAL SUPPORT CONTACTED THE CUSTOMER TWO ADDITIONAL TIMES TRYING TO OBTAIN THE RESOLUTION FOR THIS ALLEGED ISSUE. NO RESPONSE HAS BEEN RECEIVED FROM THE ACCOUNT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem · 1

HILL-ROM TECHNICAL SUPPORT RECEIVED A REPORT FROM THE ACCOUNT STATING THE PATIENT POSITIONING MODULE WOULD NOT SET. THE BED WAS LOCATED IN THE MED/SURG DEPARTMENT AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
254429	ADVANTA 2 BED	A/C POWERED ADJUSTABLE HOSPITAL BED	FNL	HILLROM DE MEXICO S DE RL DE CV	1190

Patients

Seq	Age	Sex	Outcome	Treatment
1