MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO S3 EX - 3005; BED, AC POWERED, ADJUSTABLE HOSPITAL

Model Number 3005

Device Problem Device Fell (4014)

Patient Problems Bruise/Contusion (1754); Hair Loss (1877); Head Injury (1879); Hearing Impairment (1881); Laceration(s) (1946); Pain (1994); Numbness (2415)

Event Date 03/05/2021

Event Type  malfunction  

Event Description

It was reported that a patient was on a stryker bed following a neurosurgery when the iv pole broke and hit the patient on the head on the opposite side from where the surgery had been performed.It was reported that this led to a substantial knot and indentation in his skull resulting in pain, bleeding, numbness, ringing in his ears, loss of hair, and disfiguration.Details about treatment have been requested but have not been provided at this time.

Event Description

It was reported that a patient was on a stryker bed following a neurosurgery when the iv pole broke and hit the patient on the head on the opposite side from where the surgery had been performed.It was reported that this led to pain, ringing in the ears, and numbness.This was reportedly treated with tylenol.

Manufacturer Narrative

The b5 summary, b1, and section h codes have been updated to reflect the completed investigation.This was initially reported as a serious injury but the investigation and communication with the user facility identified that this was a minor injury.

Manufacturer Narrative

Some section h codes were submitted in error in the previous supplemental.This has been corrected.

Event Description

It was reported that a patient was on a stryker bed following a neurosurgery when the iv pole broke and hit the patient on the head on the opposite side from where the surgery had been performed.It was reported that this led to pain, ringing in the ears, and numbness.This was reportedly treated with tylenol.

• Brand Name: S3 EX - 3005
• 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: 12583898
• MDR Text Key: 274968457
• Report Number: 0001831750-2021-01342
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 07613327278309
• UDI-Public: 07613327278309
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3005
• Device Catalogue Number: 3005S3EX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2021
• 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