MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, PATIENT ROTATION, POWERED

Catalog Number UNK_MED

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Dyspnea (1816)

Event Date 04/13/2017

Event Type  Injury  

Event Description

The customer reported that they are having issues with sliding x-ray cassettes under patients with their new icu beds' mattress covers.It was further alleged that a patient was moved in order to put an x-ray cassette under her, and the movement caused her breathing to become unstable, which required ventilation.No product defects were alleged.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: BED, PATIENT ROTATION, POWERED
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: chanda burghard ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 6560306
• MDR Text Key: 74935717
• Report Number: 0001831750-2017-00193
• Device Sequence Number: 1
• Product Code: IKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/13/2017
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1