RESPONDER RESPONDER IV *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-09-09 for RESPONDER RESPONDER IV * manufactured by Rauland-borg Corporation.

Event Text Entries

[1661871] Biomedical engineering responded to a call from a nursing unit in our new bed tower concerning intermittent "aux" alarms. Investigation revealed two rauland "fams" (fire alarm module)that were hot to the touch. Removal of the "fams" restored normal function. The "fams" had been "ty-rapped" together during installation. The vendor service rep replaced the devices and noticed that when the "ty-rap" was cut, the rj-45 connector pins had pushed through the heat-shrink insulation on both "fams. " these punctures resulted in an unintended electrical connection between the devices. Last week, one of our biomedical techs compared the construction of a faulty "fam" to a ncssplit4 from the same manufacturer and noticed that rauland has incorporated a piece of puncture-resistant insulating material into the splitter insulation. The tech has speculated that perhaps someone at rauland recognized the potential for problematic punctures in the production packaging of the splitter. However if that is true, it was not applied to the production of "fams". Our facility has 440 of these devices in use currently in our new bed tower.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1845157
• MDR Report Key: 1845157
• Date Received: 2010-09-09
• Date of Report: 2010-09-09
• Date of Event: 2010-08-29
• Report Date: 2010-09-09
• Date Reported to FDA: 2010-09-09
• Date Added to Maude: 2010-09-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: RESPONDER
• Generic Name: NURSE CALL SYSTEM
• Product Code: IQA
• Date Received: 2010-09-09
• Model Number: RESPONDER IV
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: RAULAND-BORG CORPORATION
• Manufacturer Address: 1802 WEST CENTRAL RD MOUNT PROSPECT IL 60056 US 60056

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-09-09