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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; BED, PATIENT ROTATION, POWERED
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STRYKER MEDICAL-KALAMAZOO ISOLIBRIUM SUPPORT SURFACE - D; BED, PATIENT ROTATION, POWERED Back to Search Results
Model Number 2972
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem Pain (1994)
Event Date 12/18/2020
Event Type  malfunction  
Manufacturer Narrative
The customer has not identified a specific unit or made one available for evaluation.
 
Event Description
It was reported that the max inflate on the mattress had not inflated it to the degree a nurse had expected.The nurse tried to boost the patient and sustained an unspecified back injury while doing so.No treatment details have been provided.No impact or adverse consequence to the patient has been reported.
 
Manufacturer Narrative
The section h codes have been updated to more accurately reflect the completed investigation.
 
Event Description
It was reported that the max inflate on the mattress had not inflated it to the degree a nurse had expected.The nurse tried to boost the patient and sustained an unspecified back injury while doing so.No treatment details have been provided.No impact or adverse consequence to the patient has been reported.
 
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Brand Name
ISOLIBRIUM SUPPORT SURFACE - D
Type of Device
BED, PATIENT ROTATION, POWERED
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key11172632
MDR Text Key226896733
Report Number0001831750-2021-00018
Device Sequence Number1
Product Code IKZ
UDI-Device Identifier07613327278453
UDI-Public07613327278453
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number2972
Device Catalogue Number2972000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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