MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ZM-541PA; TRANSMITTER

Model Number ZM-541PA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

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 he has eight (8) spo2 probes that are being used with the transmitters and they are all malfunctioning.Customer advises four (4) of the devices will not illuminate (the probe), two (2) of the probes will not work unless he puts pressure on the side of the connector.Additionally he has 1 that reads 87%, and only 87%.The 8th unit reads 85-86%.He also states the nursing staff complains that the readings for spo2 are low.

Manufacturer Narrative

Manufacturer narrative: the customer reported that he has eight (8) spo2 probes that are being used with the transmitters and they are all malfunctioning.Customer advises four (4) of the devices will not illuminate (the probe), two (2) of the probes will not work unless he puts pressure on the side of the connector.Additionally, he has 1 that reads 87%, and only 87%.The 8th unit reads 85-86%.He also states the nursing staff complains that the readings for spo2 are low.Only 7 of the reported 8 cables were in quarantine.An evaluation was performed on 7 of the tl-201t spo2 cables.It was found that one cable read low.The other 6 sensors did not light up or get any readings at all.The customer was sent an exchange probe.If additional information becomes available.

• Brand Name: ZM-541PA
• Type of Device: TRANSMITTER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, japan 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; gunma 161-8 560; JA 161-8560
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgm; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580 ; 2687488
• MDR Report Key: 5269084
• MDR Text Key: 32882478
• Report Number: 8030229-2015-00425
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/04/2015,11/04/2015

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-541PA
• Device Catalogue Number: ZM-541PA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2015
• Distributor Facility Aware Date: 11/04/2015
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2015
• Initial Date Manufacturer Received: 12/04/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2017
• 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