MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO UNKNOWN_MEDICAL_PRODUCT; BED, AC POWERED ADJUSTABLE HOSPITAL

Catalog Number UNK_MED

Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

It was reported that a patient on an unspecified bed had developed a head injury from rubbing their head against the bedrail, although no specific severity or injury details have been provided at the time of reporting.

Manufacturer Narrative

The initial mdr for this complaint reported that an injury was caused by the bed.It was later determined that the injury was due to an eeg device the patient was wearing, not the bed.There was no alleged deficiency with the bed.

Event Description

It was reported that a patient on an unspecified bed had developed a head injury from rubbing their head against the bedrail.It was later determined that the injury was due to an eeg device the patient was wearing, not the bed.There was no alleged deficiency with the bed.

• Brand Name: UNKNOWN_MEDICAL_PRODUCT
• Type of Device: BED, AC POWERED ADJUSTABLE HOSPITAL
• 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: brandon luckas ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16846759
• MDR Text Key: 314315497
• Report Number: 0001831750-2023-00639
• Device Sequence Number: 1
• Product Code: FNL
• 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,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK_MED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2023
• 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
• Patient Outcome(s): Other