MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD DRIVE; OVERBED TABLE

Model Number	13003
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident device: overbed table, model number # 13003 serial number # (b)(4).The investigation of incident is described as below: how many similar mdr, complaints, or service requests for the same product have you received over the past three (3) years? we have not received any similar mdr, complaints or service request for the same product over the past three years.If you have received reports of the similar problem, for each case, what was the root cause and corrective actions? n/a.Is there a change on the design of the item since then that will require a new static load test and fatigue test.There is no changes on the design of the item.Please provide a copy of the final quality inspection record on this particular piece of device bearing s/n # (b)(4).What is the manufacture date of this particular piece of device? manufacture date: 06/30/2021.
Event or Problem Description
We received the email medwatch report # 2438477-2022-00032 from our customer drive devilbiss healthcare on (b)(6) 2022, drive email content as below: the medical device involved in the incident is a overbed table, model number # 13003.The serial number is (b)(4).Please refer to the medwatch report for information about the event.As of today, the product in question has not been returned to drive medical for evaluation.Drive attachment content as below: on (b)(6) 2022, drive devilbiss healthcare was notified of an incident involving an overbed table.The end user reported as follows: "table spring sprung causing table to fly up with great force.Stuck high now.Very dangerous." the end user did not sustain any injury.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it.As the manufacturer, jumao replied as below: drive medwatch report #2438477-2022-00032, incident device: overbed table, model number # 13003, serial number # (b)(4), the investigation of incident is described as below: how many similar mdr, complaints, or service requests for the same product have you received over the past three (3) years? we have not received any similar mdr, complaints or service request for the same product over the past three years.If you have received reports of the similar problem, for each case, what was the root cause and corrective actions? n/a. is there a change on the design of the item since then that will require a new static load test and fatigue test.There is no changes on the design of the item.The static load test and fatigue test reports are shown in the attachment.Please provide a copy of the final quality inspection record on this particular piece of device bearing s/n # (b)(4).As attached.Lastly, what is the manufacture date of this particular piece of device? manufacture date: 06/30/2021.

• Brand Name: DRIVE
• Common Device Name: OVERBED TABLE
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD; no.36, danyan road; danyang city, jiangsu province 21230 0; CH 212300
• Manufacturer (Section G): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO.,LTD; no.36, danyan road; danyang city, jiangsu province 21230 0; CH 212300
• Manufacturer Contact: belinda deng ; no.36, danyan road; danyang city, jiangsu province 21230-0 ; CH 212300
• MDR Report Key: 15656105
• Report Number: 2438477-2022-00032
• Device Sequence Number: 17612897
• Product Code: INW
• UDI-Device Identifier: 00822383102979
• UDI-Public: 822383102979
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 13003
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/22/2022
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female