MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE; TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Model Number M4841A

Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437); Electrical Shorting (2926)

Patient Problem No Information (3190)

Event Date 03/01/2016

Event Type  malfunction  

Event Description

(b)(4).I expect a full written report of all actions taken to address the issues raised in this report from the manufacturer in response.Since the last report has been filed we have been able to replicate the battery overheating condition in a test setting by creating a short in the power input wires coming off of the battery.These wires do not appear to be repaired by philips when sent in.Previously we requested specifics in repair reports from philips as there is only very vague language being used to describe the repairs, and parts should be sold so repairs can be done quickly in house.What is being repaired? can these parts be sold individually? there are some dimensional variations among standard aa batteries, the batteries in use in our hospital are on the larger end of these variations.We instituted a trial using a new battery manufacturer across all of our transmitters which was roughly 2mm shorter in overall length.We posited that the shorted length could cause less flexing of the input wires and hopefully not create the short condition.This was not the case and several units have failed with different batteries, removing that possible cause.Three units failed during the test, and 2 of those had been recently repaired (in some unknown capacity) by philips.Our cleaning solutions were also under scrutiny during this.We have confirmed with staff that only pdi sani-cloth af3 is being used on these devices, which is on the approved cleaner list.This report is being filed because this is an ongoing issue with continued incidents and no acceptable response from the manufacturer.

• Brand Name: INTELLIVUE
• Type of Device: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• MDR Report Key: 5549772
• MDR Text Key: 41975798
• Report Number: 5549772
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2016,04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M4841A
• Other Device ID Number: 0106201842
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Outcome(s): Other