O&M HALYARD, INC. PATIENT WARMING SYSTEM M1000 CONTROL UNIT; TEMPERATURE MANAGEMENT PRODUCTS
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Model Number 01000-01 |
Device Problem
Overheating of Device (1437)
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Patient Problem
Burn(s) (1757)
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Event Date 03/18/2022 |
Event Type
Injury
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Event Description
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Patient 2 of 2.A fda medwatch report (b)(4) was received 04aug2022.The report states that there were two patients that had second degree burns to their backs which increased their hospital stay.This hospital was using a kimberly-clark intraoperative warming system m1000 (made by o&m halyard, inc.) during cardiac surgery starting (b)(6) 2022.The gel pads are applied to the back with a warming console that has water.A joint patient safety report was done on both cases.One patient required wound care service.
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Manufacturer Narrative
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The product involved in the event was not available for return.A follow-up report will be provided upon conclusion of investigation.All information reasonably known as of 31aug2022 has been included in this medical device report.The information provided by o&m halyard, inc.Represents all of the known information at this time.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.Device not returned.
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Manufacturer Narrative
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The device was sent to nortech (the device servicer) where calibration, functional, and safety tests were performed.The devices passed all tests and nortech was not able to duplicate the customer experience.We will continue to monitor the field performance of this product.All information reasonably known as of (b)(6) 2023 has been included in this medical device report.The information provided by(b)(6).Represents all of the known information at this time.O&m halyard, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to (b)(4), in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
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