MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70

Model Number 862451

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that the arm on the wall broke and the mp70 fell, resulting in a lot of physical damage.The device was not in use on a patient at the time of the event.

Manufacturer Narrative

The following functional tests were performed: the remote service engineer (rse) spoke to the customer, and the customer stated that the arm on the wall broke, and the mp70 had a lot of physical damage.The customer was checking what options were available to have the unit repaired.The rse informed the customer that the unit is end of life, and we no longer have any parts or offer any repairs.The rse sent the end of life letter service bulletin (sb) (b)(4) to the customer.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was confirmed we are unable to confirm the final disposition of the device, because the customer was provided the end of life letter (b)(4).It is unknown how the customer decided to proceed with the device.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : device was determined to be end of life.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 17987345
• MDR Text Key: 326308832
• Report Number: 9610816-2023-00540
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Device Operator: Health Professional
• Device Model Number: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/17/2004
• 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