MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE TRX+; PHYSIOLOGICAL MONITOR, CARDIOVASCULAR

Catalog Number 989803196951

Device Problems Melted (1385); Overheating of Device (1437); Smoking (1585); Device Inoperable (1663); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2017

Event Type  malfunction  

Event Description

Staff reported: bedside registered nurse went into room after report of telemetry box not working.Upon picking up box, it was very hot and began smoking.She opened the battery case to find that the alkaline batteries were fully melted and shorting out.Device brought to clinical engineering for evaluation.This transmitter uses two aa size alkaline disposable batteries.One battery had overheated and ejected material around the negative terminal.The other battery was undamaged and measured 1.6v (full).It appears part of the insulation around the negative terminal of the battery was damaged at some point and allowed a short circuit against the battery contact in the device.It is not known how the battery insulation was damaged, but it is very thin.The shorted battery became hot enough to melt and split the plastic sleeve that covers the battery.A considerable amount of material was ejected from the shorted battery and assumed to be caustic.The transmitter was still functional and sustained only cosmetic damage.There was no patient or staff injury reported.

• Brand Name: INTELLIVUE TRX+
• Type of Device: PHYSIOLOGICAL MONITOR, CARDIOVASCULAR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• MDR Report Key: 6659878
• MDR Text Key: 78163105
• Report Number: 6659878
• Device Sequence Number: 1
• Product Code: MHX
• 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: 06/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 989803196951
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1