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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC PAGEWRITER TC30 CARDIOGRAPH

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PHILIPS NORTH AMERICA LLC PAGEWRITER TC30 CARDIOGRAPH Back to Search Results
Model Number 860306
Device Problem Insufficient Information (3190)
Patient Problem No Patient Involvement (2645)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
The customer reported that following a fall, the device had several broken parts.Good faith efforts (gfe) have been made by the investigator to obtain additional information regarding how the device fell without a response.No additional information has been provided.There was no reported patient impact/injury.
 
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Brand Name
PAGEWRITER TC30 CARDIOGRAPH
Type of Device
PAGEWRITER TC30 CARDIOGRAPH
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
3000 minuteman road
andover MA 01810
Manufacturer Contact
tara mackinnon
222 jacobs street
cambridge, MA 02141
MDR Report Key11376362
MDR Text Key233456545
Report Number1218950-2021-10024
Device Sequence Number1
Product Code DPS
UDI-Device Identifier00884838081123
UDI-Public00884838081123
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K080999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number860306
Device Catalogue Number860306
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date02/09/2021
Date Manufacturer Received02/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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