• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILATOR Back to Search Results
Model Number M3535A
Device Problems Failure to Read Input Signal (1581); No Tactile Prompts/Feedback (4024)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Event Description
It was reported to philips that during navigation, the arrow to go up does not work.
 
Event Description
It was reported to philips that during navigation, the arrow to go up does not work.The device was evaluated by the customer with assistance from a philips remote service engineer (rse).The reported issue was confirmed and the cause was traced to a faulty mrx kit display 3 & face plate assembly.Based on the conclusion of the evaluation, it was determined that this was a malfunction of the mrx kit display 3 & face plate assembly.The customer ordered a replacement mrx kit display 3 & face plate assembly to return the device to working condition.The device remains at the customer site.There is no indication of a systemic problem.No further investigation or action is warranted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEARTSTART MRX MONITOR/DEFIB
Type of Device
DEFIBRILATOR
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
betonio olympia
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key13712780
MDR Text Key286882820
Report Number3030677-2022-01476
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public00884838000018
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation Other
Type of Report Initial,Followup
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
Device Model NumberM3535A
Device Catalogue NumberM3535A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/07/2022
Initial Date FDA Received03/09/2022
Supplement Dates Manufacturer Received03/28/2022
Supplement Dates FDA Received04/14/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-