MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO LD304 MATERNITY BED; TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)

Catalog Number 4701000000

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

Upon evaluation by the stryker service technician, it was found the left crank weldment had broken.Replacement parts have been ordered, but the customer requested closure of the service report, indicating they will be holding the bed as is until completion of their investigation.

Event Description

It was reported the bed tipped to the side when the patient¿s mother had her arms draped over the bed siderails.Allegedly the bed ¿broke¿ and tilted to the patient left side, and was caught by the nurse on duty who injured her lower back.As the bed returned to the upright position, it caused pain to the patient¿s mother¿s shoulder.It was further reported the patient¿s mother had a prior shoulder injury.It was reported by the labor and delivery supervisor that the nurse and the mother were both examined in the er and had x-rays performed as a diagnostic measure.The nurse¿s x-ray was negative, but she did miss a couple of shifts at work due to soreness.The supervisor also indicated she believed the nurse may have received medication for pain.The supervisor did not have any details on the severity or treatment of the patient¿s mother¿s reported injury.While no adverse events were reported relating to the patient and infant, they were kept 24 hours for observation.

Manufacturer Narrative

Supplemental submitted to indicate the product has been repaired and returned to service.

Event Description

It was reported the bed tipped to the side when the patient¿s mother had her arms draped over the bed siderails.Allegedly the bed ¿broke¿ and tilted to the patient left side, and was caught by the nurse on duty who injured her lower back.As the bed returned to the upright position, it caused pain to the patient¿s mother¿s shoulder.It was further reported the patient¿s mother had a prior shoulder injury.It was reported by the labor and delivery supervisor that the nurse and the mother were both examined in the er and had x-rays performed as a diagnostic measure.The nurse¿s x-ray was negative, but she did miss a couple of shifts at work due to soreness.The supervisor also indicated she believed the nurse may have received medication for pain.The supervisor did not have any details on the severity or treatment of the patient¿s mother¿s reported injury.While no adverse events were reported relating to the patient and infant, they were kept 24 hours for observation.

• Brand Name: LD304 MATERNITY BED
• Type of Device: TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)
• 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: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7962327
• MDR Text Key: 123666302
• Report Number: 0001831750-2018-01090
• Device Sequence Number: 1
• Product Code: HDD
• UDI-Device Identifier: 07613327278095
• UDI-Public: 07613327278095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 4701000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2008
• 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