MAUDE Adverse Event Report: PHILIPS VISICU THE M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130; PHYSIOLOGICAL TRANSMITTER AND RECEIVER

Model Number M3815-80009

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/29/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in this issue.Photograph confirmed the issue.Investigation is underway and cause and correction will be determined.A supplemental report will be submitted to provide an update.

Event Description

Customer identified a problem with labeling on a blood pressure cuff that (b)(4) supplied to the customer.The label stated the measurement was 19-31 cm.The size printed on the cuff states 24-36 cm.The customer called for clarification.There was no patient involved in this issue.

Manufacturer Narrative

Upon review of the history of the label, it was determined that the measurement interval printed on the label applied by philips' supplier has been incorrect since the label's origination more than 10 years ago.Further, philips investigated the large and small bp cuff labels and determined those were also incorrect.A correction was made to product in inventory and changes were made to the label to correct.

Event Description

This supplemental report is submitted for additional information available.

• Brand Name: THE M3810A PHILIPS TELEMONITORING SYSTEM WITH EDEVICE BRIDGED130
• Type of Device: PHYSIOLOGICAL TRANSMITTER AND RECEIVER
• Manufacturer (Section D): PHILIPS VISICU; 217 e. redwood st.; suite 1900; baltimore MD 21202
• Manufacturer (Section G): PHILIPS LIFELINE; 111 lawrence st.; framingham MA 01702 8156
• Manufacturer Contact: cathleen hargreaves ; 217 e. redwood st.; suite 1900; baltimore, MD 21202 ; 4108434590
• MDR Report Key: 5536454
• MDR Text Key: 41525888
• Report Number: 1125873-2016-00023
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/29/2016,07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M3815-80009
• Device Catalogue Number: M3815-80009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Report to Manufacturer: 02/29/2016
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 1125873-05-13-16-012-C
• Patient Sequence Number: 1