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

Catalog Number UNK_MED

Device Problem No Audible Alarm (1019)

Patient Problem Fall (1848)

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that the nurse call cable broke away from the wall resulting in the clinician not being alerted to a patient fall that required unspecified medical intervention.

Event Description

It was reported that the nurse call cable broke away from the wall resulting in the clinician not being alerted to a patient fall that resulted in pain which was treated with ice.

Manufacturer Narrative

B5 updated to reflect the completed complaint investigation.

Manufacturer Narrative

Section h codes updated to reflect the findings of the completed investigation.

Event Description

It was reported that the nurse call cable broke away from the wall resulting in the clinician not being alerted to a patient fall that required unspecified medical intervention.

• 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: 18942551
• MDR Text Key: 338147046
• Report Number: 0001831750-2024-00333
• 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,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• 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: 02/23/2024
• 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