MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PHILIPS; ADULT NIBP AIRHOSE

Model Number M1599B

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems High Blood Pressure/ Hypertension (1908); Injury (2348)

Event Date 08/15/2016

Event Type  Injury  

Manufacturer Narrative

It is unknown if emergent care/treatment was necessary.Therefore, this is being considered as a serious injury.At this time, there is indication of user error since it was reported that the philips nbp hose was modified to accept a third party (non-philips) cuff.As a result, we are considering this to be reportable.A follow up report will be submitted once the investigation is complete.

Event Description

The user reported elevated blood pressures readings (example 220/210).The readings were reported as atypical.It was also reported that a patient was injured due to the reported erroneous readings, but the extent of the patient's injuries is not known at this time.The user is reportedly "hesitant to provide more details." initial investigation found that the philips nbp hose had been modified to accept a non-philips cuff.

Manufacturer Narrative

Field service engineer was dispatched to the customer site to evaluate the mms device, since the customer suspected this is what was causing the reported inaccurate nibp readings.The fse performed performance verification on the mms and the mms passed all testing.Additional information was obtained about the reported incident, which indicated that the customer modified the philips nibp hose to use critikon cuffs (critikon adult soft-cuff [ref]: sft-a2-2a -23-33 cm).The term modified was defined further to mean that the philips nibp hose¿s rectus connector was cut off and a critikon two-hose adaptor (for a two hose cuff) was put in its place.The customer stated that they believe this incident is possible a nursing error.The customer requested that philips provide documentation of the accessories that philips supports and what accessories they should be using.The customer reported elevated blood pressures readings.It was also reported that a patient was injured due to the reported erroneous readings, but the extent of the patient¿s injuries was not provided by the customer.The customer refused to release any patient information to philips including any vitals at the time of the event.The investigation determined that modification of the philips nibp hose by the customer in order to use critikon cuffs (non- philips-approved) may have contributed to the incident with the patient.We have no reason to believe an unmodified cuff would have contributed to this issue.Use of non-philips-approved accessories is contrary to the instructions for use (ifu).Accordingly, we are not considering this a device malfunction.

• Brand Name: PHILIPS
• Type of Device: ADULT NIBP AIRHOSE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: richa shah ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 5945990
• MDR Text Key: 54551219
• Report Number: 1218950-2016-05627
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1599B
• Device Lot Number: NOT PROVIDE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: 08/15/2016
• Supplement Dates FDA Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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