MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-530PA; TRANSMITTER

Model Number ZM-530PA

Device Problems No Device Output (1435); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the blood pressure and pulse-ox readings were dropping off the screen of the transmitter device (zm-530pa).No consequence or impact to the patient was reported.The customer indicated that they will not be providing any additional information regarding the event.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.

Event Description

The customer reported that the blood pressure and pulse-ox readings were dropping off the screen of the transmitter device (zm-530pa).No consequence or impact to the patient was reported.

Event Description

The customer reported that the blood pressure and pulse-ox readings were dropping off the screen of the transmitter device (zm-530pa).No consequence or impact to the patient was reported.

Manufacturer Narrative

Details of the complaint: on 09/16/19, customer at (b)(6) reported the following issue: blood pressure and pulse ox no longer on the patient monitor in the room.This was provided to nka technical support (ts) from the hospital's department logs.The incident occurred on (b)(4) 2019 in the room/box #528 for the transmitter (zm-530pa sn: ni).No further information will be provided from the hospital.Service requested: none.Service performed: none.Investigation result: there was a reported incident in which the blood pressure (bp) and pulse ox were reported to no longer be on the patient monitor.The details surrounding the incident were not provided and information on the extent of any troubleshooting is unknown.From the information available, it is unclear if the issue was related to the bp and spo2 readings, or if it was relating to the physical attachment of the bp cuff and pulse oximeter.Investigation conclusion: based on the available information, it is not possible to make any conclusions on the root cause.

• Brand Name: ZM-530PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 116-8 560; JA 116-8560
• MDR Report Key: 9126428
• MDR Text Key: 198928371
• Report Number: 8030229-2019-00489
• Device Sequence Number: 1
• Product Code: DRT
• UDI-Device Identifier: 04931921115091
• UDI-Public: 4931921115091
• Combination Product (y/n): N
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/27/2019

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: ZM-530PA
• Device Catalogue Number: ZM-530PA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2019
• Distributor Facility Aware Date: 12/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2019
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/26/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1