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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 ONSITE DEFIB, US ENGLISH, EXCHANGE; AED

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PHILIPS NORTH AMERICA LLC HS1 ONSITE DEFIB, US ENGLISH, EXCHANGE; AED Back to Search Results
Model Number M5066A
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It has been reported that the device may be prematurely draining batteries.
 
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Brand Name
HS1 ONSITE DEFIB, US ENGLISH, EXCHANGE
Type of Device
AED
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
shannon decker
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key12100737
MDR Text Key259415959
Report Number3030677-2021-12630
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
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 Lay User/Patient
Device Model NumberM5066A
Device Catalogue Number453564428191
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2021
Is the Reporter a Health Professional? No
Distributor Facility Aware Date06/22/2021
Initial Date Manufacturer Received 06/22/2021
Initial Date FDA Received07/01/2021
Supplement Dates Manufacturer Received08/05/2021
Supplement Dates FDA Received08/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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