MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH UNKNOWN PATIENT MONITORING BEDSIDE MONITOR; UNK013-BEDSIDE MONITOR

Catalog Number UNK013-BEDSIDE MONITOR

Device Problems Increase in Pressure (1491); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Rupture (2208); Muscle/Tendon Damage (4532)

Event Date 05/01/2022

Event Type  Injury  

Event Description

The customer reported patient had a ruptured tendon due to a blood pressure cuff when connected to an unknown monitor.It is unknown if the device was in use at time of event, and there was adverse event reported.

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Manufacturer Narrative

Philips received a complaint on an unknown patient monitoring bedside monitor indicating that the non-invasive blood pressure (nibp) cuff caused a bicep tendon rupture in (b)(6) 2022.A good faith effort (gfe) was performed to attempt to obtain the product number and/or serial number of the bedside monitor, but no additional details were provided.The customer advised that due to the time lapse between when the patient was in the hospital and when the issue was brought to their attention, the hospital could not determine what equipment was used on the patient.There is insufficient information to complete a full investigation into the issue, as the model number of the bedside monitor was not provided.Since it was determined that the nibp cuffs used at the time of the incident were medline cuffs, it is not possible to verify if these are validated cuffs, as it is unknown which bedside monitor was being used at the time of the incident.It was recommended to only use philips approved accessories.Product and 501k information is not available after several good faith effort attempts were made.If information is made available supplemental report will be sent.H3 other text : product/serial number not provided.

• Brand Name: UNKNOWN PATIENT MONITORING BEDSIDE MONITOR
• Type of Device: UNK013-BEDSIDE MONITOR
• 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: 18204919
• MDR Text Key: 328919218
• Report Number: 3010359222-2023-00020
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: UNK013-BEDSIDE MONITOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2024
• 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