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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTSINE TECHNOLOGIES LTD PACKAGE, 360P, PP03, UK, 360-STR-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR

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HEARTSINE TECHNOLOGIES LTD PACKAGE, 360P, PP03, UK, 360-STR-UK-10; AUTOMATED EXTERNAL DEFIBRILLATOR Back to Search Results
Catalog Number 360-STR-UK-10
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Manufacturer Narrative
Heartsine has requested return of the complaint device.Upon its receipt, the device will be investigated and a follow up report submitted within 30 days documenting the findings.
 
Event Description
Absence of voice prompts may lead to adverse consequences if device use is required.No patient involved in this event.
 
Event Description
Absence of voice prompts may lead to adverse consequences if device use is required.No patient involved in this event.
 
Manufacturer Narrative
Heartsine's investigation of the device confirmed the reported fault as the device would not issue audio prompts.Upon visual inspection, the reported fault was attributed to a broken speaker cable which was identified as being broken in the region where the rim of the upper case meets the lower case.This indicates that the cable had been damaged during pairing of the two cases at manufacture.Whilst the device performed a test shock during testing, absence of voice prompts may lead to an inability understanding how to use the device correctly which could result in adverse consequences.
 
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Brand Name
PACKAGE, 360P, PP03, UK, 360-STR-UK-10
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATOR
Manufacturer (Section D)
HEARTSINE TECHNOLOGIES LTD
207 airport road west
belfast BT3 9 ED
EI  BT3 9ED
MDR Report Key12106032
MDR Text Key262166126
Report Number3004123209-2021-00175
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
P160008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/07/2021
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 No Information
Device Catalogue Number360-STR-UK-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2021
Initial Date Manufacturer Received 06/18/2021
Initial Date FDA Received07/02/2021
Supplement Dates Manufacturer Received08/31/2021
Supplement Dates FDA Received09/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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