Model Number 20 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/31/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) (b)(4) of the (b)(6) parliament and of the council.Stryker evaluated the customer's device and verified the reported issue.It was observed that the pin in the therapy socket was broken.After replacing the therapy connector and performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
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Event Description
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A customer contacted stryker to report that their device gave 'abnormal energy' messages during patient use.As a result, defibrillation therapy would not be available, if needed.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.
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Manufacturer Narrative
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Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Stryker evaluated the customer's device and verified the reported issue.It was observed that the pin in the therapy socket was broken.After replacing the therapy connector and performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
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Event Description
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A customer contacted stryker to report that their device gave 'abnormal energy' messages during patient use.As a result, defibrillation therapy would not be available, if needed.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.
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Manufacturer Narrative
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Additional mfg narrative of the initial medwatch report indicates stryker evaluated the customer's device and verified the reported issue.It was observed that the pin in the therapy socket was broken.After replacing the therapy connector and performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.Section h10 and/or h11, additional mfg narrative of the initial medwatch report should indicate a third-party service agent evaluated the customer's device and verified the reported issue.It was observed that the pin in the therapy socket was broken.After replacing the therapy connector and performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
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Event Description
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A customer contacted stryker to report that their device gave 'abnormal energy' messages during patient use.As a result, defibrillation therapy would not be available, if needed.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.
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Manufacturer Narrative
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The removed therapy connector was further evaluated at stryker product analysis center (pac).It was observed that pin 6 of the therapy connector was blocked by a stuck piece that appears to be a broken off pin.The cause of the reported issue was determined to be due to a fractured pin in the therapy connector.
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Event Description
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A customer contacted stryker to report that their device gave 'abnormal energy' messages during patient use.As a result, defibrillation therapy would not be available, if needed.The patient associated with the reported event did not survive.The customer confirmed that the device use did not contribute to the patient outcome.
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Search Alerts/Recalls
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