MAUDE Adverse Event Report: CRITIKON DE MEXICO S. DE R.L. DE C.V. DINAMAP PRO 400; PHYSIOLOGICAL PATIENT MONITOR

Device Problems Break (1069); Battery Problem (2885)

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

Event Date 12/23/2013

Event Type  malfunction  

Event Description

The customer reported that the battery of the dinamap pro 400 shorted out and caused damage to the device.There was no reported patient injury associated with this event.

Manufacturer Narrative

A follow-up report will be submitted when the investigation is complete.

• Brand Name: DINAMAP PRO 400
• Type of Device: PHYSIOLOGICAL PATIENT MONITOR
• Manufacturer (Section D): CRITIKON DE MEXICO S. DE R.L. DE C.V.; juarez ; MX
• Manufacturer (Section G): CRITIKON DE MEXICO S. DE R.L. DE C.V.; juarez ; MX
• Manufacturer Contact: joy sonsalla ; 3000 n. grandview blvd.; waukesha, WI 53188 ; 2625482661
• MDR Report Key: 3695843
• MDR Text Key: 20011925
• Report Number: 3008729547-2014-00003
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K014255
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/23/2013
• Initial Date FDA Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1